Trial Outcomes & Findings for Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk (NCT NCT02991118)

NCT ID: NCT02991118

Last Updated: 2020-04-27

Results Overview

Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\[post-baseline value minus baseline value\] divided by \[baseline value\]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (atherosclerotic cardiovascular diseases \[ASCVD\] and heterozygous familial hypercholesterolemia \[HeFH\]) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 are imputed using multiple imputation method taking into account adherence to treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 779 participants
• Primary outcome timeframe: Baseline; Week 12
• Results posted on: 2020-04-27

Participant Flow

A total of 779 participants were randomized 2:1 to receive either bempedoic acid or placebo.

The study consisted of 3 periods: a 1-week screening period; a 4-week single-blind, placebo run-in period; and a 52-week double-blind, randomized treatment period.

Participant milestones

Measure	Placebo Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Overall Study STARTED	257	522
Overall Study COMPLETED	250	490
Overall Study NOT COMPLETED	7	32

Reasons for withdrawal

Measure	Placebo Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Overall Study Death	3	8
Overall Study Protocol Violation	0	3
Overall Study Physician Decision	0	1
Overall Study Moved out of the country	0	1
Overall Study Adverse Event	2	2
Overall Study Withdrawal by Subject	1	7
Overall Study Could not attend study visits	0	1
Overall Study Lost to Follow-up	1	9

Baseline Characteristics

Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk

Baseline characteristics by cohort

Measure	Placebo n=257 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=522 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Total n=779 Participants Total of all reporting groups
LDL-C category <130 mg/dL	173 Participants n=5 Participants	365 Participants n=7 Participants	538 Participants n=5 Participants
LDL-C category ≥130 and <160 mg/dL	45 Participants n=5 Participants	89 Participants n=7 Participants	134 Participants n=5 Participants
LDL-C category ≥160 mg/dL	39 Participants n=5 Participants	68 Participants n=7 Participants	107 Participants n=5 Participants
Mean non-high-density lipoprotein cholesterol (non-HDL-C)	153.7 mg/dL STANDARD_DEVIATION 44.36 • n=5 Participants	150.7 mg/dL STANDARD_DEVIATION 42.75 • n=7 Participants	151.7 mg/dL STANDARD_DEVIATION 43.28 • n=5 Participants
Mean total cholesterol (TC)	204.8 mg/dL STANDARD_DEVIATION 46.06 • n=5 Participants	202.1 mg/dL STANDARD_DEVIATION 42.71 • n=7 Participants	203.0 mg/dL STANDARD_DEVIATION 43.83 • n=5 Participants
Mean apolipoprotein B (apoB)	118.6 mg/dL STANDARD_DEVIATION 30.53 • n=5 Participants	116.2 mg/dL STANDARD_DEVIATION 29.58 • n=7 Participants	117.0 mg/dL STANDARD_DEVIATION 29.90 • n=5 Participants
Median high-sensitivity C-reactive protein (hsCRP)	1.880 milligrams per Liter n=5 Participants	1.610 milligrams per Liter n=7 Participants	1.700 milligrams per Liter n=5 Participants
Median triglycerides	143.00 mg/dL n=5 Participants	139.25 mg/dL n=7 Participants	140.00 mg/dL n=5 Participants
Concomitant lipid-modifying therapy (LMT) medications Statins	232 Participants n=5 Participants	478 Participants n=7 Participants	710 Participants n=5 Participants
Estimated glomerular filtration rate (eGFR) category ≥60 to <90 mL/min/1.73 m^2	164 Participants n=5 Participants	338 Participants n=7 Participants	502 Participants n=5 Participants
Disease history Diabetes	81 Participants n=5 Participants	155 Participants n=7 Participants	236 Participants n=5 Participants
Disease history Impaired fasting glucose	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Body mass index (BMI)	30.64 kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 5.048 • n=5 Participants	30.01 kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 5.192 • n=7 Participants	30.22 kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 5.150 • n=5 Participants
Estimated glomerular filtration rate (eGFR) category ≥90 mL/min/1.73 m^2	56 Participants n=5 Participants	107 Participants n=7 Participants	163 Participants n=5 Participants
Estimated glomerular filtration rate (eGFR) category <60 mL/min/1.73 m^2	37 Participants n=5 Participants	77 Participants n=7 Participants	114 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=5 Participants	24 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	244 Participants n=5 Participants	491 Participants n=7 Participants	735 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Mean low-density lipoprotein cholesterol (LDL-C)	122.4 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 38.30 • n=5 Participants	119.4 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 37.75 • n=7 Participants	120.43 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 37.931 • n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 8.73 • n=5 Participants	64.1 years STANDARD_DEVIATION 8.82 • n=7 Participants	64.3 years STANDARD_DEVIATION 8.79 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	194 Participants n=7 Participants	283 Participants n=5 Participants
Sex: Female, Male Male	168 Participants n=5 Participants	328 Participants n=7 Participants	496 Participants n=5 Participants
Concomitant lipid-modifying therapy (LMT) medications Fibrates	17 Participants n=5 Participants	26 Participants n=7 Participants	43 Participants n=5 Participants
Concomitant lipid-modifying therapy (LMT) medications Nicotinic acid and derivatives	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Concomitant lipid-modifying therapy (LMT) medications Other lipidmodifying therapies	38 Participants n=5 Participants	63 Participants n=7 Participants	101 Participants n=5 Participants
Concomitant lipid-modifying therapy (LMT) medications Bile acid sequestrants	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
History of atherosclerotic cardiovascular disease (ASCVD)	241 Participants n=5 Participants	495 Participants n=7 Participants	736 Participants n=5 Participants
History of HeFH	16 Participants n=5 Participants	27 Participants n=7 Participants	43 Participants n=5 Participants
History of impaired fasting glucose	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Background LMT Statins with or without other LMTs	228 Participants n=5 Participants	470 Participants n=7 Participants	698 Participants n=5 Participants
Background LMT Statins without other LMTs	196 Participants n=5 Participants	416 Participants n=7 Participants	612 Participants n=5 Participants
Background LMT Statins with other LMTs	32 Participants n=5 Participants	54 Participants n=7 Participants	86 Participants n=5 Participants
Background LMT Other LMTs without statins	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Background LMT No LMT or statin	14 Participants n=5 Participants	30 Participants n=7 Participants	44 Participants n=5 Participants
Disease history Hypertension	224 Participants n=5 Participants	438 Participants n=7 Participants	662 Participants n=5 Participants
Disease history Coronary heart disease	205 Participants n=5 Participants	432 Participants n=7 Participants	637 Participants n=5 Participants
Statin intensity Low intensity or no statin	40 Participants n=5 Participants	78 Participants n=7 Participants	118 Participants n=5 Participants
Statin intensity Moderate intensity	82 Participants n=5 Participants	166 Participants n=7 Participants	248 Participants n=5 Participants
Statin intensity High intensity	135 Participants n=5 Participants	278 Participants n=7 Participants	413 Participants n=5 Participants
Numer of participants receiving ezetimibe	24 Participants n=5 Participants	39 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set: all randomized participants

Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (atherosclerotic cardiovascular diseases [ASCVD] and heterozygous familial hypercholesterolemia [HeFH]) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 are imputed using multiple imputation method taking into account adherence to treatment.

Outcome measures

Measure	Placebo n=257 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=522 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)	2.35 percent change Standard Error 1.446	-15.07 percent change Standard Error 1.073

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Full Analysis Set: all randomized participants

Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 24 were imputed using multiple imputation method taking into account adherence to treatment.

Outcome measures

Measure	Placebo n=257 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=522 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 24 in LDL-C	2.66 percent change Standard Error 1.910	-12.10 percent change Standard Error 1.479

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set: all randomized participants

Baseline is defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing non-HDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.

Outcome measures

Measure	Placebo n=257 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=522 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	2.28 percent change Standard Error 1.351	-10.75 percent change Standard Error 0.952

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set: all randomized participants

Baseline is defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing TC data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.

Outcome measures

Measure	Placebo n=257 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=522 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)	1.26 percent change Standard Error 1.010	-9.94 percent change Standard Error 0.688

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set: all randomized participants

Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing apo B data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.

Outcome measures

Measure	Placebo n=257 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=522 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 12 in Apolipoprotein b (Apo B)	3.73 percent change Standard Error 1.340	-9.29 percent change Standard Error 0.851

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100.

Outcome measures

Measure	Placebo n=240 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=467 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)	-9.366 percent change Interval -36.32 to 35.241	-18.699 percent change Interval -46.067 to 23.864

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data.

Outcome measures

Measure	Placebo n=253 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=498 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Change From Baseline to Week 12 in LDL-C	0.0 mg/dL Standard Deviation 30.62	-21.2 mg/dL Standard Deviation 30.82

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data.

Outcome measures

Measure	Placebo n=247 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=485 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Change From Baseline to Week 24 in LDL-C	-1.0 mg/dL Standard Deviation 37.51	-18.7 mg/dL Standard Deviation 35.76

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline is defined as the mean of the TG values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in TG was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.

Outcome measures

Measure	Placebo n=253 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=499 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 12 in Triglycerides (TGs)	6.12 percent change Standard Error 2.294	11.01 percent change Standard Error 2.312

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline is defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.

Outcome measures

Measure	Placebo n=253 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=499 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 12 in HDL-C	-0.25 percent change Standard Error 0.864	-6.38 percent change Standard Error 0.741

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.

Outcome measures

Measure	Placebo n=237 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=467 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 52 in LDL-C	-0.97 percent change Standard Error 1.830	-13.24 percent change Standard Error 1.412

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 24

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.

Outcome measures

Measure	Placebo n=247 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=485 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 24 in Non-HDL-C	2.44 percent change Standard Error 1.611	-10.19 percent change Standard Error 1.200

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.

Outcome measures

Measure	Placebo n=237 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=467 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 52 in Non-HDL-C	-0.42 percent change Standard Error 1.605	-10.34 percent change Standard Error 1.150

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 24

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.

Outcome measures

Measure	Placebo n=247 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=486 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 24 in TC	1.52 percent change Standard Error 1.216	-9.25 percent change Standard Error 0.857

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.

Outcome measures

Measure	Placebo n=237 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=467 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 52 in TC	-1.89 percent change Standard Error 1.199	-10.25 percent change Standard Error 0.828

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 24

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.

Outcome measures

Measure	Placebo n=144 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=294 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 24 in Apo B	4.39 percent change Standard Error 2.090	-8.61 percent change Standard Error 1.267

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.

Outcome measures

Measure	Placebo n=237 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=464 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 52 in Apo B	3.01 percent change Standard Error 1.502	-6.56 percent change Standard Error 0.983

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 24

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100.

Outcome measures

Measure	Placebo n=127 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=271 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 24 in hsCRP	1.563 percent change Interval -32.174 to 47.5	-24.107 percent change Interval -51.502 to 14.035

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100.

Outcome measures

Measure	Placebo n=237 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=465 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Percent Change From Baseline to Week 52 in hsCRP	-6.250 percent change Interval -39.286 to 41.81	-16.727 percent change Interval -50.877 to 31.429

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set. Only participants with available data were analyzed.

Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data. Change from Baseline in LDL-C was analyzed using an ANCOVA model with change from baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and baseline as a covariate.

Outcome measures

Measure	Placebo n=237 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=467 Participants Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Change From Baseline to Week 52 in LDL-C	-4.71 mg/dL Standard Error 2.216	-19.78 mg/dL Standard Error 1.433

Adverse Events

Placebo

Serious events: 48 serious events

Other events: 88 other events

Deaths: 2 deaths

Bempedoic Acid

Serious events: 106 serious events

Other events: 211 other events

Deaths: 6 deaths

Serious adverse events

Measure	Placebo n=257 participants at risk Participants received placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=522 participants at risk Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Blood and lymphatic system disorders Microcytic anaemia	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Acute coronary syndrome	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Acute left ventricular failure	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Acute myocardial infarction	1.2% 3/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Angina pectoris	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	2.3% 12/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Angina unstable	2.3% 6/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.7% 9/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Atrial fibrillation	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.77% 4/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Atrioventricular block second degree	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Cardiac arrest	0.78% 2/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Cardiac failure	0.78% 2/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Cardiac failure chronic	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.77% 4/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Cardiac failure congestive	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Cardiovascular disorder	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Coronary artery disease	2.3% 6/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.3% 7/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Coronary artery occlusion	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Coronary artery stenosis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Myocardial infarction	0.78% 2/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Myocardial ischaemia	1.6% 4/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Ventricular arrhythmia	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Cardiac disorders Ventricular fibrillation	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Ear and labyrinth disorders Vertigo	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Ear and labyrinth disorders Vertigo positional	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Abdominal pain upper	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Dyspepsia	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Gastric antral vascular ectasia	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Gastritis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Hiatus hernia	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Ileus	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Ileus paralytic	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Inguinal hernia	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Intestinal perforation	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Large intestine perforation	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Oesophagitis	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Peritoneal adhesions	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
General disorders Asthenia	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
General disorders Chest pain	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
General disorders Death	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
General disorders Exercise tolerance decreased	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
General disorders Non-cardiac chest pain	0.78% 2/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
General disorders Pain	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
General disorders Vascular stent occlusion	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Hepatobiliary disorders Cholelithiasis	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Hepatobiliary disorders Hepatic cirrhosis	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Cellulitis	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Clostridium difficile infection	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Cystitis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Diverticulitis	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Fungal infection	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Gastroenteritis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Lower respiratory tract infection	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Pneumonia	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Pneumonia bacterial	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Septic shock	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Urethral stricture post infection	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Urinary tract infection	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.57% 3/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Contusion	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Femoral neck fracture	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Gas poisoning	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Kidney rupture	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Limb injury	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.57% 3/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Investigations Ejection fraction decreased	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Metabolism and nutrition disorders Dehydration	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Metabolism and nutrition disorders Hypokalaemia	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.78% 2/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.96% 5/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Periostitis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour of the lung	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Carotid artery stenosis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Carpal tunnel syndrome	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Cervical radiculopathy	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Encephalopathy	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Hyporeflexia	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Ischaemic stroke	0.78% 2/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.77% 4/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Post stroke epilepsy	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Syncope	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.77% 4/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Psychiatric disorders Depression	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Renal and urinary disorders Acute kidney injury	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Renal and urinary disorders Perinephritis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Renal and urinary disorders Urinary incontinence	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Renal and urinary disorders Urinary retention	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 4/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Skin and subcutaneous tissue disorders Diabetic foot	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Surgical and medical procedures Supportive care	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Vascular disorders Aortic aneurysm	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Vascular disorders Deep vein thrombosis	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Vascular disorders Iliac artery occlusion	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Vascular disorders Peripheral arterial occlusive disease	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.38% 2/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Vascular disorders Peripheral artery stenosis	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Vascular disorders Peripheral ischaemia	0.00% 0/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.19% 1/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Vascular disorders Subclavian artery thrombosis	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	0.00% 0/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.

Other adverse events

Measure	Placebo n=257 participants at risk Participants received placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.	Bempedoic Acid n=522 participants at risk Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Blood and lymphatic system disorders Anaemia	1.2% 3/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	2.7% 14/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Gastrointestinal disorders Diarrhoea	2.7% 7/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	3.1% 16/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
General disorders Fatigue	3.5% 9/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.1% 6/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Bronchitis	2.3% 6/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.3% 7/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Lower respiratory tract infection	2.7% 7/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.3% 7/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Nasopharyngitis	5.1% 13/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	5.2% 27/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Upper respiratory tract infection	3.5% 9/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	3.6% 19/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Infections and infestations Urinary tract infection	1.9% 5/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	4.6% 24/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Investigations Blood uric acid increased	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	2.7% 14/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Metabolism and nutrition disorders Diabetes mellitus	2.3% 6/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.9% 10/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Metabolism and nutrition disorders Gout	0.78% 2/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	2.1% 11/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Metabolism and nutrition disorders Hyperuricaemia	1.9% 5/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	4.2% 22/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.7% 7/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.9% 10/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 8/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	3.4% 18/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Muscle spasms	1.2% 3/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	2.1% 11/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Myalgia	3.1% 8/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	2.9% 15/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.2% 3/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	2.1% 11/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Musculoskeletal and connective tissue disorders Pain in extremity	0.39% 1/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	2.1% 11/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Dizziness	3.5% 9/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.5% 8/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Nervous system disorders Headache	2.7% 7/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.9% 10/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.
Vascular disorders Hypertension	2.3% 6/257 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.	1.3% 7/522 • up to Week 52 Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \>=1 dose of IMP.

Additional Information

Medical Director

Esperion Therapeutics, Inc.

Phone: 1-833-377-7633

Email: medinfo@esperion.com

Results disclosure agreements

• Principal investigator is a sponsor employee If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.
• Publication restrictions are in place

Restriction type: OTHER