Trial Outcomes & Findings for Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) (NCT NCT02876835)

NCT ID: NCT02876835

Last Updated: 2024-04-02

Results Overview

Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction \[MI\] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied \[\*\] number of participants with at least 1 event) divided by \[/\] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3872 participants
• Primary outcome timeframe: Up to 4.3 person-years for CV follow-up time period
• Results posted on: 2024-04-02

Participant Flow

This was a multicenter study conducted across 39 countries. Participants were randomized to receive either daprodustat or darbepoetin alfa.

A total of 3872 participants were enrolled in the study.

Participant milestones

Measure	Daprodustat Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Run-in Period: Placebo (Week-4 to Day 1) STARTED	1937	1935
Run-in Period: Placebo (Week-4 to Day 1) COMPLETED	1937	1935
Run-in Period: Placebo (Week-4 to Day 1) NOT COMPLETED	0	0
Treatment Period (51.1 Month) STARTED	1937	1935
Treatment Period (51.1 Month) COMPLETED	1873	1870
Treatment Period (51.1 Month) NOT COMPLETED	64	65

Reasons for withdrawal

Measure	Daprodustat Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Treatment Period (51.1 Month) Other	1	0
Treatment Period (51.1 Month) Investigator Site Closed	6	13
Treatment Period (51.1 Month) Withdrawal by Subject	32	23
Treatment Period (51.1 Month) Lost to Follow-up	25	29

Baseline Characteristics

Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

Baseline characteristics by cohort

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).	Total n=3872 Participants Total of all reporting groups
Age, Continuous	64.8 Years STANDARD_DEVIATION 14.03 • n=93 Participants	64.9 Years STANDARD_DEVIATION 13.83 • n=4 Participants	64.8 Years STANDARD_DEVIATION 13.93 • n=27 Participants
Sex: Female, Male Female	1102 Participants n=93 Participants	1071 Participants n=4 Participants	2173 Participants n=27 Participants
Sex: Female, Male Male	835 Participants n=93 Participants	864 Participants n=4 Participants	1699 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	88 Participants n=93 Participants	100 Participants n=4 Participants	188 Participants n=27 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	58 Participants n=93 Participants	71 Participants n=4 Participants	129 Participants n=27 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	245 Participants n=93 Participants	232 Participants n=4 Participants	477 Participants n=27 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	216 Participants n=93 Participants	229 Participants n=4 Participants	445 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	183 Participants n=93 Participants	185 Participants n=4 Participants	368 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	19 Participants n=93 Participants	18 Participants n=4 Participants	37 Participants n=27 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	1079 Participants n=93 Participants	1037 Participants n=4 Participants	2116 Participants n=27 Participants
Race/Ethnicity, Customized Mixed Asian Race	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Mixed Race	36 Participants n=93 Participants	51 Participants n=4 Participants	87 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (Intent-to-treat \[ITT\]) Population comprised of all randomized participants. Participants were analyzed according to the treatment to which they were randomized.

Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction [MI] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied [*] number of participants with at least 1 event) divided by [/] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)	10.86 Events per 100 person years Interval 9.8 to 12.02	10.63 Events per 100 person years Interval 9.58 to 11.77

PRIMARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)

Population: All Randomized (ITT) Population.

Blood samples were collected from participants for Hgb measurements. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of covariance (ANCOVA) model with terms for treatment, Baseline Hgb, current ESA use and region.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52)	0.74 Grams per deciliter Standard Error 0.019	0.66 Grams per deciliter Standard Error 0.019

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to MACE defined as the time to first occurrence of CEC adjudicated MACE was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariate. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis)	10.86 Events per 100 person years Interval 9.8 to 12.02	10.63 Events per 100 person years Interval 9.58 to 11.77

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated MACE or thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism) was analyzed using a Cox proportional hazards regression model with with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period	12.34 Events per 100 person years Interval 11.19 to 13.57	11.77 Events per 100 person years Interval 10.65 to 12.98

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated MACE or hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period	13.16 Events per 100 person years Interval 11.97 to 14.44	12.22 Events per 100 person years Interval 11.08 to 13.46

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed. Additionally, this analysis population was restricted to those with a Baseline eGFR \>=15milliliter per minute (mL/min).

Progression of CKD defined as: 40% decline in estimated glomerular filtration rate (eGFR) from Baseline or end stage renal disease (ESRD) as defined by either initiating chronic dialysis for >=90 days or not initiating chronic dialysis when dialysis is indicated or kidney transplantation. Time to first occurrence of CKD progression was analyzed using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) +1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1220 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1265 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period	17.55 Events per 100 person years Interval 15.74 to 19.51	17.76 Events per 100 person years Interval 15.97 to 19.7

SECONDARY outcome

Timeframe: Up to 4.3 person-years for vital status follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated all-cause mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the vital status follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period	8.35 Events per 100 person years Interval 7.43 to 9.35	8.27 Events per 100 person years Interval 7.35 to 9.26

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated CV mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period	3.02 Events per 100 person years Interval 2.48 to 3.65	2.55 Events per 100 person years Interval 2.06 to 3.13

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated MI (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period	2.94 Events per 100 person years Interval 2.4 to 3.56	2.76 Events per 100 person years Interval 2.24 to 3.36

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated stroke (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period	1.26 Events per 100 person years Interval 0.92 to 1.69	0.95 Events per 100 person years Interval 0.66 to 1.33

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Number of participants with adjudicated MACE or hospitalization for heart failure (recurrent events analysis) is presented, categorized by number of occurrences of adjudicated MACE or hospitalization for heart failure per participant.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) Occurrences per participant: 0	1493 Participants	1518 Participants
Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) Occurrences per participant: 1	318 Participants	317 Participants
Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) Occurrences per participant: 2	76 Participants	64 Participants
Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) Occurrences per participant: 3	26 Participants	22 Participants
Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) Occurrences per participant: 4	14 Participants	9 Participants
Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) Occurrences per participant: 5	5 Participants	3 Participants
Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) Occurrences per participant: 6	1 Participants	0 Participants
Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) Occurrences per participant: 7	4 Participants	1 Participants
Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis) Occurrences per participant: 8	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated CV mortality or non-fatal MI was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period	5.36 Events per 100 person years Interval 4.62 to 6.18	4.98 Events per 100 person years Interval 4.27 to 5.77

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

All-cause hospitalization events were hospital admissions recorded on the hospitalization electronic case report form (eCRF) form with a hospitalization duration >=24 hours. Time to first occurrence of all-cause hospitalization was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period	41.13 Events per 100 person years Interval 38.59 to 43.8	38.99 Events per 100 person years Interval 36.54 to 41.56

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

All-cause hospital re-admissions within 30days are defined as hospital admissions recorded on hospitalization electronic case record form with hospitalization duration of >=24 hours and admission date within 30days following previous discharge date of all-cause hospitalization event, where previous hospitalization was >=24hours.Time to first occurrence of all-cause hospital re-admission within 30days was analyzed using Cox proportional hazards regression model with treatment group, current ESA use at randomization and region as covariates.Time to the first occurrence was computed as(event date - randomization date)+1. Incidence rate per 100 person years calculated as(100*number of participants with at least 1event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period	7.78 Events per 100 person years Interval 6.87 to 8.79	7.55 Events per 100 person years Interval 6.65 to 8.55

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated MACE or hospitalization for heart failure or thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period	14.60 Events per 100 person years Interval 13.33 to 15.96	13.32 Events per 100 person years Interval 12.11 to 14.61

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period	4.05 Events per 100 person years Interval 3.41 to 4.78	3.30 Events per 100 person years Interval 2.73 to 3.96

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population.

Time to first occurrence of adjudicated thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period	1.81 Events per 100 person years Interval 1.39 to 2.31	1.43 Events per 100 person years Interval 1.07 to 1.89

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Time to first occurrence of confirmed 40% decline in eGFR was analyzed using a Fine & Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1220 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1265 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Confirmed 40% Decline in eGFR During CV Events Follow-up Time Period	8.21 Events per 100 person years Interval 7.04 to 9.52	8.90 Events per 100 person years Interval 7.69 to 10.24

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Time to first occurrence of chronic dialysis was analyzed using a Fine & Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Chronic dialysis is defined by either initiating dialysis for >=90 days or not initiating chronic dialysis when dialysis is indicated. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1220 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1265 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Chronic Dialysis During CV Events Follow-up Time Period	12.20 Events per 100 person years Interval 10.74 to 13.81	12.06 Events per 100 person years Interval 10.63 to 13.62

SECONDARY outcome

Timeframe: Up to 4.3 person-years for CV follow-up time period

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Time to first occurrence of kidney transplant were analyzed using a Fine & Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

Outcome measures

Measure	Daprodustat n=1220 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1265 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Time to First Occurrence of Kidney Transplant During CV Events Follow-up Time Period	1.00 Events per 100 person years Interval 0.63 to 1.5	1.14 Events per 100 person years Interval 0.75 to 1.66

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and Week 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected from participants for Hgb measurements. Change from Baseline was defined as post-randomization value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using mixed model repeated measures (MMRM) model fitted from Baseline up to Week 52, excluding values collected during the stabilization period, with factors for treatment, time, current ESA use, region, Baseline Hgb and Baseline Hgb by time and treatment by time interactions.

Outcome measures

Measure	Daprodustat n=1557 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1556 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in Post-randomization Hgb Levels at Week 52	0.76 Grams per deciliter Standard Error 0.029	0.73 Grams per deciliter Standard Error 0.029

SECONDARY outcome

Timeframe: Week 28 to Week 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.

Outcome measures

Measure	Daprodustat n=1491 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1520 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)	1167 Participants	1063 Participants

SECONDARY outcome

Timeframe: Week 28 to Week 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / [Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)].

Outcome measures

Measure	Daprodustat n=1461 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1483 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis	70.5 Percentage of days Interval 0.0 to 100.0	63.2 Percentage of days Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Week 28 to Week 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / [Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)].

Outcome measures

Measure	Daprodustat n=1461 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1483 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis	70.5 Percentage of days Interval 0.0 to 100.0	63.2 Percentage of days Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Week 28 to end of study (4.3 person-years for follow-up time period)

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / [Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)].

Outcome measures

Measure	Daprodustat n=1469 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1489 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Non-inferiority Analysis	66.1 Percentage of days Interval 0.0 to 100.0	62.1 Percentage of days Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Week 28 to end of study (4.3 person-years for follow-up time period)

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / [Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)].

Outcome measures

Measure	Daprodustat n=1469 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1489 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Superiority Analysis	66.1 Percentage of days Interval 0.0 to 100.0	62.1 Percentage of days Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Baseline (Week -4) and Week 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is the average (BP) in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using MMRM model with treatment group + time + current ESA use at randomization + region + Baseline value + Baseline value*time + treatment group*time, using an unstructured covariance matrix. Data for post-dialysis BP measurements have been presented.

Outcome measures

Measure	Daprodustat n=1913 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1884 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52 SBP, n=1913, 1884	-0.62 Millimeter of mercury Standard Error 0.488	-1.17 Millimeter of mercury Standard Error 0.479
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52 DBP, n=1912, 1884	0.06 Millimeter of mercury Standard Error 0.267	-0.59 Millimeter of mercury Standard Error 0.262
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52 MAP, n=1912, 1884	-0.17 Millimeter of mercury Standard Error 0.300	-0.77 Millimeter of mercury Standard Error 0.294

SECONDARY outcome

Timeframe: Baseline (Week -4) and 51.1 months

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value. Data for post-dialysis BP measurements have been presented.

Outcome measures

Measure	Daprodustat n=1919 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1884 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in SBP, DBP, MAP at End of Treatment SBP, n=1919, 1884	-1.19 Millimeter of mercury Standard Error 0.395	-1.10 Millimeter of mercury Standard Error 0.398
Change From Baseline in SBP, DBP, MAP at End of Treatment DBP, n=1918, 1884	-0.26 Millimeter of mercury Standard Error 0.229	-0.38 Millimeter of mercury Standard Error 0.231
Change From Baseline in SBP, DBP, MAP at End of Treatment MAP, n=1918, 1884	-0.57 Millimeter of mercury Standard Error 0.248	-0.62 Millimeter of mercury Standard Error 0.251

SECONDARY outcome

Timeframe: Day 1 to end of treatment (51.1 months)

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

BP exacerbation event (based on post-dialysis) was defined as: SBP >= 25 millimeter of mercury (mmHg) increased from Baseline or SBP >=180 mmHg; DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the negative binomial model with treatment, current ESA use at randomization and region as covariates and the logarithm of time on-treatment as an offset variable. Data for post-dialysis BP measurements have been presented.

Outcome measures

Measure	Daprodustat n=1919 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1884 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years	138.50 Events per 100 participant years Interval 128.58 to 149.18	157.35 Events per 100 participant years Interval 146.3 to 169.23

SECONDARY outcome

Timeframe: Day 1 to end of treatment (51.1 months)

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

BP exacerbation was defined as: SBP >= 25 mmHg increased from Baseline or SBP >=180 mmHg; DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. Number of participants with at least one BP exacerbation event is presented.

Outcome measures

Measure	Daprodustat n=1919 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1884 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Number of Participants With at Least One BP Exacerbation Event During Study	939 Participants	1012 Participants

SECONDARY outcome

Timeframe: Day 1 to 51.1 months

Population: All Randomized (ITT) Population.

Percentage of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.

Outcome measures

Measure	Daprodustat n=1937 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1935 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria	2.0 Percentage of participants	3.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher score represents better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Outcome measures

Measure	Daprodustat n=1238 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1227 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 Week 8, n=1238,1187	0.42 Scores on a scale Standard Error 0.169	0.78 Scores on a scale Standard Error 0.172
Change From Baseline in On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 Week 12, n=1237,1227	0.60 Scores on a scale Standard Error 0.171	0.71 Scores on a scale Standard Error 0.172
Change From Baseline in On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 Week 28, n=968,956	0.16 Scores on a scale Standard Error 0.197	0.04 Scores on a scale Standard Error 0.198
Change From Baseline in On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 Week 52, n=804,780	-0.32 Scores on a scale Standard Error 0.218	-0.12 Scores on a scale Standard Error 0.221

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Outcome measures

Measure	Daprodustat n=1238 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1227 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 8, n=1238,1187	0.08 Scores on a scale Standard Error 0.217	0.37 Scores on a scale Standard Error 0.221
Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 12, n=1237,1227	0.02 Scores on a scale Standard Error 0.223	0.18 Scores on a scale Standard Error 0.224
Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 28, n=968,956	-0.35 Scores on a scale Standard Error 0.244	-0.02 Scores on a scale Standard Error 0.245
Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 52, n=804,780	-0.71 Scores on a scale Standard Error 0.290	-0.35 Scores on a scale Standard Error 0.294

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain (b pain), general health (GH), mental health (MH), role-emotional (RE) (role limitations caused by emotional problems), role-physical (RP) (role limitations caused by physical problems), social functioning (SF), physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline (BL) was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Outcome measures

Measure	Daprodustat n=1238 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1227 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Bodily pain: Week 8, n=1238,1187	0.11 Scores on a scale Standard Error 0.221	0.45 Scores on a scale Standard Error 0.225
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Bodily pain: Week 12, n=1237,1227	0.35 Scores on a scale Standard Error 0.223	0.50 Scores on a scale Standard Error 0.224
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Bodily pain: Week 28, n=968,956	-0.48 Scores on a scale Standard Error 0.261	0.02 Scores on a scale Standard Error 0.263
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Bodily pain: Week 52, n=804,780	-0.34 Scores on a scale Standard Error 0.283	0.13 Scores on a scale Standard Error 0.288
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 General health: Week 8, n=1238,1187	0.36 Scores on a scale Standard Error 0.171	0.43 Scores on a scale Standard Error 0.174
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 General health: Week 12, n=1237,1227	0.28 Scores on a scale Standard Error 0.174	0.48 Scores on a scale Standard Error 0.175
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 General health: Week 28, n=968,956	0.14 Scores on a scale Standard Error 0.200	0.04 Scores on a scale Standard Error 0.201
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 General health: Week 52, n=804,780	-0.27 Scores on a scale Standard Error 0.220	-0.19 Scores on a scale Standard Error 0.224
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Mental health: Week 8, n=1238,1187	-0.19 Scores on a scale Standard Error 0.204	0.12 Scores on a scale Standard Error 0.208
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Mental health: Week 12, n=1237,1227	-0.07 Scores on a scale Standard Error 0.210	-0.09 Scores on a scale Standard Error 0.211
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Mental health: Week 28, n=968,956	-0.67 Scores on a scale Standard Error 0.231	-0.37 Scores on a scale Standard Error 0.232
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Mental health: Week 52, n=804,780	-0.85 Scores on a scale Standard Error 0.271	-0.61 Scores on a scale Standard Error 0.275
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Role-emotional: Week 8, n=1238,1187	0.45 Scores on a scale Standard Error 0.253	0.54 Scores on a scale Standard Error 0.258
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Role-emotional: Week 12, n=1237,1227	0.17 Scores on a scale Standard Error 0.258	0.43 Scores on a scale Standard Error 0.259
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Role-emotional: Week 28, n=968,956	-0.30 Scores on a scale Standard Error 0.290	0.07 Scores on a scale Standard Error 0.292
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Role-emotional: Week 52, n=804,780	-0.90 Scores on a scale Standard Error 0.339	-0.38 Scores on a scale Standard Error 0.344
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Role-physical: Week 8, n=1238,1187	0.33 Scores on a scale Standard Error 0.202	0.83 Scores on a scale Standard Error 0.205
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Role-physical: Week 12, n=1237,1227	0.40 Scores on a scale Standard Error 0.203	0.73 Scores on a scale Standard Error 0.204
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Role-physical: Week 28, n=968,956	0.06 Scores on a scale Standard Error 0.230	0.00 Scores on a scale Standard Error 0.232
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Role-physical: Week 52, n=804,780	-0.63 Scores on a scale Standard Error 0.259	-0.44 Scores on a scale Standard Error 0.263
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Social functioning: Week 8, n=1238,1187	0.19 Scores on a scale Standard Error 0.224	0.82 Scores on a scale Standard Error 0.228
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Social functioning: Week 12, n=1237,1227	0.21 Scores on a scale Standard Error 0.224	0.53 Scores on a scale Standard Error 0.225
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Social functioning: Week 28, n=968,956	0.04 Scores on a scale Standard Error 0.247	0.17 Scores on a scale Standard Error 0.249
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 Social functioning: Week 52, n=804,780	-0.58 Scores on a scale Standard Error 0.282	-0.20 Scores on a scale Standard Error 0.286

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Outcome measures

Measure	Daprodustat n=1238 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1227 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 8, n=1238,1187	0.35 Scores on a scale Standard Error 0.192	0.90 Scores on a scale Standard Error 0.195
Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 12, n=1237,1227	0.62 Scores on a scale Standard Error 0.200	0.74 Scores on a scale Standard Error 0.201
Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 28, n=968,956	0.22 Scores on a scale Standard Error 0.222	0.32 Scores on a scale Standard Error 0.223
Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 52, n=804,780	-0.14 Scores on a scale Standard Error 0.250	0.35 Scores on a scale Standard Error 0.253

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Outcome measures

Measure	Daprodustat n=1238 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1227 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 8, n=1238,1187	0.51 Scores on a scale Standard Error 0.200	0.83 Scores on a scale Standard Error 0.203
Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 12, n=1237,1227	0.65 Scores on a scale Standard Error 0.195	0.52 Scores on a scale Standard Error 0.196
Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 28, n=968,956	0.05 Scores on a scale Standard Error 0.224	-0.10 Scores on a scale Standard Error 0.225
Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 Week 52, n=804,780	-0.69 Scores on a scale Standard Error 0.262	-0.37 Scores on a scale Standard Error 0.266

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and Week 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

EQ-5D-5L is self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.

Outcome measures

Measure	Daprodustat n=443 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=399 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in On-treatment Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52	-0.0253 Scores on a scale Standard Error 0.00842	-0.0018 Scores on a scale Standard Error 0.00883

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and Week 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Outcome measures

Measure	Daprodustat n=443 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=399 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in On-treatment EQ Visual Analogue Scale (EQ-VAS) at Week 52	-0.7 Scores on a scale Standard Error 0.78	-1.4 Scores on a scale Standard Error 0.82

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 8, 12, 28, 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy (LE)/Weak scale consisting of 10 items; 2.Chest Pain (CP)/Shortness of Breath (SOB) scale consisting of 4 items; and 3.Cognitive (Cog) scale consisting of 3 items. The 4 CKD-AQ single items are: shortness of breath, no activity; severity-short breath (S-SB), resting; difficulty standing (diff. std.)for long time (LT) and difficulty sleeping (diff sleep). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Outcome measures

Measure	Daprodustat n=1341 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1360 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Tired/Low energy/Weak domain: Week 8,n=1340,1294	1.72 Scores on a scale Standard Error 0.424	2.94 Scores on a scale Standard Error 0.429
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Tired/Low energy/Weak domain: Week 12,n=1341,1360	2.11 Scores on a scale Standard Error 0.437	3.08 Scores on a scale Standard Error 0.434
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Tired/Low energy/Weak domain: Week 28,n=1053,1047	1.27 Scores on a scale Standard Error 0.495	1.87 Scores on a scale Standard Error 0.496
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Tired/Low energy/Weak domain: Week 52,n=870,865	0.20 Scores on a scale Standard Error 0.554	1.77 Scores on a scale Standard Error 0.556
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Chest pain/SOB domain: Week 8,n=1340,1294	0.63 Scores on a scale Standard Error 0.358	1.83 Scores on a scale Standard Error 0.363
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Chest pain/ SOB domain: Week 12,n=1341,1360	0.88 Scores on a scale Standard Error 0.370	1.53 Scores on a scale Standard Error 0.368
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Chest pain/ SOB domain: Week 28,n=1053,1047	0.01 Scores on a scale Standard Error 0.424	0.53 Scores on a scale Standard Error 0.425
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Chest pain/ SOB domain: Week 52,n=870,865	-0.71 Scores on a scale Standard Error 0.471	0.47 Scores on a scale Standard Error 0.473
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Cognitive domain: Week 8,n=1340,1294	0.13 Scores on a scale Standard Error 0.413	0.89 Scores on a scale Standard Error 0.419
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Cognitive domain: Week 12,n=1341,1360	-0.17 Scores on a scale Standard Error 0.414	1.01 Scores on a scale Standard Error 0.412
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Cognitive domain: Week 28,n=1053,1047	-0.40 Scores on a scale Standard Error 0.468	0.37 Scores on a scale Standard Error 0.469
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Cognitive domain: Week 52,n=870,865	-2.00 Scores on a scale Standard Error 0.526	-0.35 Scores on a scale Standard Error 0.527
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 SOB, no activity: Week 8,n=1340,1294	-0.1 Scores on a scale Standard Error 0.42	1.0 Scores on a scale Standard Error 0.42
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 SOB, no activity: Week 12,n=1341,1360	0.1 Scores on a scale Standard Error 0.43	0.4 Scores on a scale Standard Error 0.42
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 SOB, no activity: Week 28,n=1053,1047	-1.1 Scores on a scale Standard Error 0.50	-0.2 Scores on a scale Standard Error 0.50
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 SOB, no activity: Week 52,n=870,865	-1.7 Scores on a scale Standard Error 0.57	-1.6 Scores on a scale Standard Error 0.57
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Severity-short breath, Resting: Week 8,n=1340,1294	-0.3 Scores on a scale Standard Error 0.40	0.8 Scores on a scale Standard Error 0.40
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Severity-short breath, Resting:Week 12,n=1341,1360	-0.3 Scores on a scale Standard Error 0.42	0.0 Scores on a scale Standard Error 0.42
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Severity-short breath, Resting:Week 28,n=1053,1047	-1.1 Scores on a scale Standard Error 0.48	-0.7 Scores on a scale Standard Error 0.48
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Severity-short breath, Resting:Week 52,n=870,865	-2.0 Scores on a scale Standard Error 0.53	-0.5 Scores on a scale Standard Error 0.53
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Diff std for long time: Week 8,n=1340,1294	1.0 Scores on a scale Standard Error 0.62	2.5 Scores on a scale Standard Error 0.63
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Diff std for long time: Week 12,n=1341,1360	0.7 Scores on a scale Standard Error 0.63	1.6 Scores on a scale Standard Error 0.62
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Diff std for long time: Week 28,n=1053,1047	0.4 Scores on a scale Standard Error 0.71	1.7 Scores on a scale Standard Error 0.71
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Diff std for long time: Week 52,n=870,865	-2.1 Scores on a scale Standard Error 0.76	1.2 Scores on a scale Standard Error 0.76
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Difficulty sleeping: Week 8,n=1340,1294	1.6 Scores on a scale Standard Error 0.60	1.1 Scores on a scale Standard Error 0.61
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Difficulty sleeping: Week 12,n=1341,1360	0.5 Scores on a scale Standard Error 0.60	2.0 Scores on a scale Standard Error 0.59
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Difficulty sleeping: Week 28,n=1053,1047	-0.7 Scores on a scale Standard Error 0.69	-0.3 Scores on a scale Standard Error 0.70
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52 Difficulty sleeping: Week 52,n=870,865	-2.6 Scores on a scale Standard Error 0.78	-0.3 Scores on a scale Standard Error 0.78

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated more disease severity. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Outcome measures

Measure	Daprodustat n=1341 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1362 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52 Week 8, n=1341,1295	0.00 Scores on a scale Standard Error 0.022	-0.02 Scores on a scale Standard Error 0.022
Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52 Week 12, n=1341,1362	0.03 Scores on a scale Standard Error 0.022	-0.02 Scores on a scale Standard Error 0.022
Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52 Week 28, n=1054,1051	0.05 Scores on a scale Standard Error 0.025	0.09 Scores on a scale Standard Error 0.025
Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52 Week 52, n=871,865	0.11 Scores on a scale Standard Error 0.028	0.06 Scores on a scale Standard Error 0.029

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and Week 52

Population: All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected to analyze estimated glomerular filtration rate. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.

Outcome measures

Measure	Daprodustat n=1869 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1868 Participants Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Change From Baseline in Post-randomization Estimated Glomerular Filtration Rate (eGFR) at Week 52	-2.88 mL per minute per 1.73 square meter Standard Error 0.193	-2.67 mL per minute per 1.73 square meter Standard Error 0.193

Adverse Events

Run-in Period: Placebo

Serious events: 63 serious events

Other events: 0 other events

Deaths: 0 deaths

Daprodustat

Serious events: 850 serious events

Other events: 851 other events

Deaths: 301 deaths

Darbepoetin Alfa

Serious events: 703 serious events

Other events: 825 other events

Deaths: 298 deaths

Serious adverse events

Measure	Run-in Period: Placebo n=3872 participants at risk Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1).	Daprodustat n=1937 participants at risk Participants received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily from randomization (Day 1) up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1933 participants at risk Participants received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) from randomization (Day 1) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Infections and infestations Tracheobronchitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Uraemic gastropathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Vascular access malfunction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Vascular pseudoaneurysm ruptured	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Ventricular tachycardia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Vomiting	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Abdominal hernia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Accelerated hypertension	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Acid base balance abnormal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Acidosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Acute abdomen	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Altered state of consciousness	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Immune system disorders Anaphylactic reaction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Angle closure glaucoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Immune system disorders Anti-neutrophil cytoplasmic antibody positive vasculitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Anuria	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Psychiatric disorders Anxiety	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Aortic dissection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Aortic intramural haematoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Appendiceal abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Appendicitis perforated	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Arrhythmia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Arteriosclerosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Arteriovenous fistula	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Arteriovenous fistula maturation failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Arteriovenous fistula site haematoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Arteriovenous fistula site pseudoaneurysm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Arteriovenous graft site infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Arteriovenous graft thrombosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Atrioventricular block second degree	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Bacteraemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Balance disorder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Basilar artery occlusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Biliary colic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Psychiatric disorders Bipolar disorder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Blood glucose increased	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Blood urea increased	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Bradyarrhythmia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Brain abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Brain stem haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Brain stem infarction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Reproductive system and breast disorders Breast mass	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Cardiac death	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Catheter site extravasation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Catheter site inflammation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Catheter site pain	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Cellulitis staphylococcal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Cerebral haematoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Cerebrovascular disorder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Cholecystitis infective	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Chronic left ventricular failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Chronic respiratory disease	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Chronic sinusitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Clostridium bacteraemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Coagulation test abnormal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Colitis microscopic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Colonic abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Complication associated with device	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Complications of transplanted kidney	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Congestive cardiomyopathy	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Coronary artery occlusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Coronary artery stenosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Cryptogenic cirrhosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Cutaneous calcification	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Cystitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Cystitis klebsiella	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Dengue fever	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Dengue haemorrhagic fever	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Product Issues Device failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Diabetic end stage renal disease	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Diabetic gastropathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Diabetic ketoacidotic hyperglycaemic coma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Diabetic vascular disorder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Discomfort	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Diverticulitis intestinal haemorrhagic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Dizziness	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Duodenitis haemorrhagic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Dysarthria	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Dystonic tremor	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Eczema infected	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Electrocardiogram QRS complex prolonged	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Electrocardiogram T wave inversion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Embolic stroke	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Embolism	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Emphysematous pyelonephritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Empyema	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Encephalitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage 0	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Enteritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Enteritis infectious	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Enterococcal sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Enterocolitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Escherichia sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Evans syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Eye haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Eyelid ptosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Gait inability	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastric perforation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Gastroenteritis bacillus	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Giant cell arteritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Glaucoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Gliosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Glomerulonephritis chronic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Glomerulonephritis membranous	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Gouty tophus	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Groin abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Haematochezia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haematological malignancy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Haemobilia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Headache	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Heart injury	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Hemiparesis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Hepatic cyst infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Hepatic encephalopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Hepatic mass	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Herpes ophthalmic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Hiatus hernia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Hydronephrosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hyperammonaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hyperinsulinaemic hypoglycaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Endocrine disorders Hyperprolactinaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hyponatraemic syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Endocrine disorders Hypothyroidism	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders IIIrd nerve paresis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders IgA nephropathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Ileus	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Social circumstances Immobile	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Incision site abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Infected fistula	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Infectious pleural effusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Infective tenosynovitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Inflammation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Psychiatric disorders Insomnia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Intercapillary glomerulosclerosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Internal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Intervertebral discitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Intracranial aneurysm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Kidney infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Immune system disorders Kidney transplant rejection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Klebsiella sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Lacunar infarction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Product Issues Lead dislodgement	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Listeria sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Lumbar radiculopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage I	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Lupus nephritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Mechanical ileus	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Meningitis viral	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Mesenteric vascular insufficiency	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Metabolic syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Metapneumovirus infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Mitral valve prolapse	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Monoparesis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Myasthenia gravis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Myocarditis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Necrobiosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Nerve root injury lumbar	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Neuropathy peripheral	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Neutropenic sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Nodal arrhythmia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Non-immune heparin associated thrombocytopenia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Obstructive nephropathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Oliguria	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Orchitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Overdose	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Pancreatic disorder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Pancreatic enzymes increased	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Paraesthesia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Endocrine disorders Parathyroid hyperplasia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Parotitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Peau d'orange	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Pelvic mass	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Peptic ulcer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Perineal abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Peripheral artery aneurysm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Phlebitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pneumonia adenoviral	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pneumonia escherichia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pneumonia influenzal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pneumonia klebsiella	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pneumonia pneumococcal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pneumonia viral	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Post procedural inflammation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Proctitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Pseudohyponatraemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pseudomembranous colitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pseudomonas bronchitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pseudomonas infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertensive crisis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pulmonary tuberculosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Putamen haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pyonephrosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Rectal abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Refeeding syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Refractory anaemia with an excess of blasts	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer recurrent	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Renal cyst infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Renal graft infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Respiratory syncytial virus infection	— 0/0 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Respiratory syncytial virus test positive	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Retinal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Retroperitoneal neoplasm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Rhegmatogenous retinal detachment	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Rhinovirus infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Right ventricular failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Sarcopenia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Reproductive system and breast disorders Scrotal swelling	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Sepsis syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Septic arthritis staphylococcal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Serratia sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Sideroblastic anaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Sinus node dysfunction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Sinusitis fungal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Sphingomonas paucimobilis infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Spinal cord infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the vulva	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Starvation ketoacidosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Stress cardiomyopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Subclavian artery stenosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Subclavian vein thrombosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Sudden cardiac death	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Psychiatric disorders Suicidal ideation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Congenital, familial and genetic disorders Syringomyelia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Thrombophlebitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Tooth abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Transaminases increased	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Tuberculosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Tubo-ovarian abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Ulcerative keratitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Umbilical hernia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Ureteritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Ureterolithiasis	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Urinary tract infection bacterial	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Urinary tract infection staphylococcal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Reproductive system and breast disorders Uterine polyp	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Vascular access site infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Vascular access site thrombosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Vascular device occlusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Vascular graft complication	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Vascular graft infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Vascular graft occlusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Vertigo CNS origin	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Ear and labyrinth disorders Vertigo positional	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Viral infection	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Vitreoretinal traction syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Wound infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Fungal infection	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Bifascicular block	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Renal artery occlusion	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Renal artery stenosis	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Urinary tract obstruction	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pneumonia	0.08% 3/3872 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	4.0% 78/1937 • Number of events 90 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	3.9% 75/1933 • Number of events 81 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Chronic kidney disease	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	4.4% 86/1937 • Number of events 90 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	2.5% 49/1933 • Number of events 52 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Acute kidney injury	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	3.6% 70/1937 • Number of events 76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	2.4% 47/1933 • Number of events 53 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Azotaemia	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	2.8% 54/1937 • Number of events 56 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.8% 35/1933 • Number of events 35 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders End stage renal disease	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	2.5% 48/1937 • Number of events 50 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.9% 36/1933 • Number of events 37 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations COVID-19	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	2.0% 39/1937 • Number of events 39 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.7% 33/1933 • Number of events 33 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Urinary tract infection	0.05% 2/3872 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.7% 33/1937 • Number of events 34 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.9% 36/1933 • Number of events 38 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Anaemia	0.08% 3/3872 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.7% 33/1937 • Number of events 34 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.6% 31/1933 • Number of events 34 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Acute myocardial infarction	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.9% 37/1937 • Number of events 40 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.3% 26/1933 • Number of events 28 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hyperkalaemia	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.3% 26/1937 • Number of events 26 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.3% 25/1933 • Number of events 26 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Cardiac failure congestive	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.5% 29/1937 • Number of events 43 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.0% 20/1933 • Number of events 23 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Fluid overload	0.05% 2/3872 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.3% 25/1937 • Number of events 27 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.2% 23/1933 • Number of events 24 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Cardiac failure	0.05% 2/3872 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.4% 28/1937 • Number of events 35 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.72% 14/1933 • Number of events 17 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Cellulitis	0.08% 3/3872 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.98% 19/1937 • Number of events 22 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.72% 14/1933 • Number of events 15 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.72% 14/1937 • Number of events 15 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.98% 19/1933 • Number of events 19 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Peritonitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.1% 21/1937 • Number of events 28 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.52% 10/1933 • Number of events 15 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Renal impairment	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	1.0% 20/1937 • Number of events 21 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.57% 11/1933 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hypoglycaemia	0.05% 2/3872 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.83% 16/1937 • Number of events 20 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.67% 13/1933 • Number of events 16 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Angina unstable	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.67% 13/1937 • Number of events 15 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.78% 15/1933 • Number of events 17 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Hypertension	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.77% 15/1937 • Number of events 16 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.57% 11/1933 • Number of events 14 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hyponatraemia	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.52% 10/1937 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.83% 16/1933 • Number of events 20 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Renal failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.77% 15/1937 • Number of events 16 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.57% 11/1933 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.57% 11/1937 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.57% 11/1933 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Cerebrovascular accident	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.67% 13/1937 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.41% 8/1933 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Coronary artery disease	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.52% 10/1937 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.57% 11/1933 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.67% 13/1937 • Number of events 14 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1933 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Femur fracture	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.41% 8/1937 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.62% 12/1933 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.46% 9/1937 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.57% 11/1933 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Angina pectoris	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.52% 10/1937 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.47% 9/1933 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Atrial fibrillation	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.57% 11/1937 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.41% 8/1933 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.62% 12/1937 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1933 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Product Issues Device malfunction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.46% 9/1937 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.47% 9/1933 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.62% 12/1937 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Death	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.67% 13/1937 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Gastroenteritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.52% 10/1933 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Lower respiratory tract infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.52% 10/1933 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Myocardial infarction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.72% 14/1937 • Number of events 14 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.62% 12/1933 • Number of events 14 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Hypertensive crisis	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.41% 8/1937 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.41% 8/1933 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Hypertensive urgency	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.47% 9/1933 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Fall	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.46% 9/1937 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Hypotension	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.52% 10/1937 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Non-cardiac chest pain	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.46% 9/1937 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Osteomyelitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.41% 8/1933 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Syncope	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.47% 9/1933 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Urosepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.52% 10/1933 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.47% 9/1933 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Cardiac arrest	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.52% 10/1937 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Cardiac failure acute	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.46% 9/1937 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Device related infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1933 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Gangrene	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.41% 8/1937 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Hypertensive emergency	0.05% 2/3872 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.41% 8/1933 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Acute left ventricular failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.62% 12/1937 • Number of events 14 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Septic shock	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Device related sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Diabetic foot	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Escherichia urinary tract infection	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Nephropathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Orthostatic hypotension	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.41% 8/1933 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1933 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Bronchitis	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1933 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Inguinal hernia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Acute coronary syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Bradycardia	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Femoral neck fracture	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Hip fracture	0.05% 2/3872 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Metabolic encephalopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pyelonephritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1933 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Transient ischaemic attack	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Upper respiratory tract infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastritis	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Ischaemic stroke	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Cardiogenic shock	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Gout	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Multiple organ dysfunction syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.36% 7/1937 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Oedema peripheral	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Suspected COVID-19	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Colitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Electrolyte imbalance	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Impaired gastric emptying	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Myocardial ischaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pyelonephritis acute	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1933 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Abdominal pain	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Abscess limb	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1933 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Aortic stenosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.31% 6/1937 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Chest pain	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Deep vein thrombosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Dehydration	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Diarrhoea	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Generalised oedema	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Influenza	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pneumonia bacterial	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Pyrexia	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Seizure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Sinus bradycardia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Urinary retention	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Blood creatinine increased	0.05% 2/3872 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations COVID-19 pneumonia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Cardiac failure chronic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Cerebral infarction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Product Issues Device occlusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Haematoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Peripheral vascular disorder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Post procedural infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1937 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Pyelonephritis chronic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Streptococcal bacteraemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.26% 5/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Arteriovenous fistula site infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Arthritis bacterial	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Asthenia	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Atrioventricular block complete	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Bile duct stone	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Cardiorenal syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Cholelithiasis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Clostridium difficile colitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Constipation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Haematuria	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hypovolaemia	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Intermittent claudication	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Psychiatric disorders Mental status changes	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.21% 4/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Oesophagitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Osteomyelitis acute	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Pericardial effusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Peritoneal dialysis complication	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Renal colic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Renal cyst haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Toxic encephalopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Vascular device infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Ear and labyrinth disorders Vertigo	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Vitreous haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Acute hepatitis B	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Aortic valve incompetence	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Aortic valve stenosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Aphasia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Appendicitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Ascites	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Catheter site infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Psychiatric disorders Confusional state	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Diverticulitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Immune system disorders Drug hypersensitivity	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Endocarditis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Endophthalmitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Fatigue	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastritis erosive	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Gastroenteritis viral	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Haemodialysis complication	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Haemorrhagic stroke	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Head injury	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Herpes zoster	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.15% 3/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Endocrine disorders Hyperparathyroidism secondary	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Large intestine perforation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Localised infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.16% 3/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Nephrogenic anaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Nephropathy toxic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Palpitations	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Pericarditis uraemic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Respiratory tract infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Troponin increased	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Uraemic encephalopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Ventricular extrasystoles	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Abdominal distension	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Alanine aminotransferase increased	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Anal abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Anticoagulation drug level above therapeutic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Aortic aneurysm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Atrial flutter	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Bronchiolitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Cardiomyopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Cataract	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Catheter site haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Cerebellar stroke	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Cerebral haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Cholecystitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Clostridium difficile infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Contusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Psychiatric disorders Delirium	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Dementia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Psychiatric disorders Depression	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Product Issues Device dislocation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Device related bacteraemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Diabetic foot infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Diabetic neuropathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Dialysis hypotension	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Diarrhoea infectious	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Diastolic dysfunction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Dizziness postural	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Encephalopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Enterobacter sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Enterococcal bacteraemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Escherichia bacteraemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Escherichia infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Extremity necrosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Fluid retention	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Food poisoning	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Fungal peritonitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Gastrointestinal infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders General physical health deterioration	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations Glomerular filtration rate decreased	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Haematemesis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Endocrine disorders Hyperparathyroidism	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Hypertensive heart disease	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Hypoglycaemic coma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Impaired healing	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Infected skin ulcer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Intercostal neuralgia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Investigations International normalised ratio increased	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Intestinal perforation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Intracranial haematoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Ischaemic skin ulcer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Jugular vein thrombosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Left ventricular dysfunction	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Left ventricular failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Limb injury	0.03% 1/3872 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Liver abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Loss of consciousness	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Malaise	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Malignant hypertension	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Melaena	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Mitral valve incompetence	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Pancreatitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Cardiac disorders Pericarditis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Peripheral artery occlusion	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Peritonitis bacterial	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Postoperative wound infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Presyncope	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Reproductive system and breast disorders Prostatitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Nervous system disorders Radiculopathy	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Immune system disorders Renal transplant failure	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Eye disorders Retinal detachment	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Soft tissue infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Staphylococcal infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Staphylococcal sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Streptococcal sepsis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Subcutaneous abscess	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Sudden death	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1937 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1933 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Vascular disorders Superior vena cava syndrome	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Product Issues Thrombosis in device	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1937 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.05% 1/1933 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.10% 2/1937 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	0.00% 0/1933 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.

Other adverse events

Measure	Run-in Period: Placebo n=3872 participants at risk Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1).	Daprodustat n=1937 participants at risk Participants received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily from randomization (Day 1) up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).	Darbepoetin Alfa n=1933 participants at risk Participants received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) from randomization (Day 1) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
Vascular disorders Hypertension	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	12.8% 247/1937 • Number of events 317 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	13.7% 264/1933 • Number of events 339 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
General disorders Oedema peripheral	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	10.2% 198/1937 • Number of events 239 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	8.4% 162/1933 • Number of events 199 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Urinary tract infection	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	8.5% 164/1937 • Number of events 245 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	7.9% 153/1933 • Number of events 199 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Diarrhoea	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	7.7% 149/1937 • Number of events 181 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	7.2% 139/1933 • Number of events 172 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Infections and infestations Nasopharyngitis	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	6.1% 118/1937 • Number of events 163 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	6.9% 133/1933 • Number of events 180 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	6.6% 128/1937 • Number of events 148 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	6.3% 122/1933 • Number of events 141 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Constipation	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	6.6% 127/1937 • Number of events 150 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	4.6% 88/1933 • Number of events 96 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Injury, poisoning and procedural complications Fall	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	5.4% 104/1937 • Number of events 128 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	4.6% 88/1933 • Number of events 119 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	4.2% 82/1937 • Number of events 95 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	5.4% 105/1933 • Number of events 110 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.
Gastrointestinal disorders Nausea	0.00% 0/3872 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	5.3% 103/1937 • Number of events 120 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.	4.3% 84/1933 • Number of events 101 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period) All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER