Trial Outcomes & Findings for Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II) (NCT NCT01730053)

Results Overview

Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

305 participants

Primary outcome timeframe

From Baseline to Week 24

Results posted on

2020-04-07

Participant Flow

The study was conducted at 79 sites in 8 countries. Overall, 672 participants were screened between 24 October 2012 and 27 September 2013, 367 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.

Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, and intensity of statin treatment (rosuvastatin 10 or 20 mg). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System (IVWRS) in a 1:1:1:1:1:1 ratio after confirmation of selection criteria.

Participant milestones

Participant milestones
Measure	Rosuvastatin 20 mg Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Overall Study STARTED	48	48	49	53	53	54
Overall Study Treated	48	48	49	53	53	54
Overall Study COMPLETED	43	34	38	45	44	41
Overall Study NOT COMPLETED	5	14	11	8	9	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Rosuvastatin 20 mg Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Overall Study Participant moved	0	0	1	0	0	0
Overall Study Physician Decision	0	0	0	1	0	0
Overall Study Adverse Event	2	6	3	3	2	2
Overall Study Poor compliance to protocol	1	2	2	0	0	2
Overall Study Other than specified	2	6	5	4	7	9

Baseline Characteristics

Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75/up to 150 + Rosuvastatin 10 mg n=49 Participants Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=54 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Total n=305 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 11.15 • n=5 Participants	60.4 years STANDARD_DEVIATION 10.38 • n=7 Participants	62.2 years STANDARD_DEVIATION 11.11 • n=5 Participants	60.6 years STANDARD_DEVIATION 10.11 • n=4 Participants	63.1 years STANDARD_DEVIATION 10.2 • n=21 Participants	57.9 years STANDARD_DEVIATION 8.86 • n=10 Participants	60.9 years STANDARD_DEVIATION 10.4 • n=115 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	22 Participants n=7 Participants	18 Participants n=5 Participants	15 Participants n=4 Participants	22 Participants n=21 Participants	26 Participants n=10 Participants	118 Participants n=115 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	26 Participants n=7 Participants	31 Participants n=5 Participants	38 Participants n=4 Participants	31 Participants n=21 Participants	28 Participants n=10 Participants	187 Participants n=115 Participants
Low density lipoprotein cholesterol (LDL-C) in mg/dL	105.9 mg/dL STANDARD_DEVIATION 36.0 • n=5 Participants	102.4 mg/dL STANDARD_DEVIATION 41.9 • n=7 Participants	107.3 mg/dL STANDARD_DEVIATION 26.4 • n=5 Participants	112.9 mg/dL STANDARD_DEVIATION 43.3 • n=4 Participants	119.0 mg/dL STANDARD_DEVIATION 48.0 • n=21 Participants	118.3 mg/dL STANDARD_DEVIATION 32.2 • n=10 Participants	111.3 mg/dL STANDARD_DEVIATION 39.0 • n=115 Participants
LDL-C in mmol/L	2.743 mmol/L STANDARD_DEVIATION 0.933 • n=5 Participants	2.653 mmol/L STANDARD_DEVIATION 1.085 • n=7 Participants	2.78 mmol/L STANDARD_DEVIATION 0.684 • n=5 Participants	2.924 mmol/L STANDARD_DEVIATION 1.122 • n=4 Participants	3.082 mmol/L STANDARD_DEVIATION 1.243 • n=21 Participants	3.065 mmol/L STANDARD_DEVIATION 0.834 • n=10 Participants	2.882 mmol/L STANDARD_DEVIATION 1.009 • n=115 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 24

Population: ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.

Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis	-16.3 percent change Standard Error 4.1	-14.4 percent change Standard Error 4.4	-50.6 percent change Standard Error 4.2	-15.9 percent change Standard Error 7.1	-11.0 percent change Standard Error 7.2	-36.3 percent change Standard Error 7.1

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.

Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule \[whatever rosuvastatin or ezetimibe\], whichever came first) (on-treatment analysis).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=46 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=51 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis	-18.3 percent change Standard Error 3.3	-20.3 percent change Standard Error 3.6	-53.5 percent change Standard Error 3.5	-17.0 percent change Standard Error 6.9	-16.5 percent change Standard Error 6.9	-41.5 percent change Standard Error 6.9

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: ITT population.

Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis	-17.1 percent change Standard Error 4.1	-17.4 percent change Standard Error 4.2	-49.6 percent change Standard Error 4.1	-22.1 percent change Standard Error 5.3	-19.3 percent change Standard Error 5.4	-32.3 percent change Standard Error 5.2

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: mITT population.

Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever rosuvastatin or ezetimibe\], whichever came first) (on-treatment analysis).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=46 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=51 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis	-17.2 percent change Standard Error 3.6	-20.3 percent change Standard Error 3.8	-52.6 percent change Standard Error 3.6	-22.9 percent change Standard Error 5.2	-21.8 percent change Standard Error 5.2	-35.1 percent change Standard Error 5.2

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=51 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=49 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis	-7.3 percent change Standard Error 3.0	-9.7 percent change Standard Error 3.1	-36.5 percent change Standard Error 3.1	-9.8 percent change Standard Error 4.1	-11.2 percent change Standard Error 4.3	-28.3 percent change Standard Error 4.3

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule \[whatever rosuvastatin or ezetimibe\], whichever came first).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=42 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=43 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=47 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis	-8.8 percent change Standard Error 2.6	-11.2 percent change Standard Error 2.7	-39.5 percent change Standard Error 2.6	-12.7 percent change Standard Error 4.0	-12.6 percent change Standard Error 4.1	-30.4 percent change Standard Error 4.2

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis	-11.3 percent change Standard Error 3.4	-13.4 percent change Standard Error 3.7	-42.7 percent change Standard Error 3.5	-11.2 percent change Standard Error 5.1	-12.9 percent change Standard Error 5.2	-31.4 percent change Standard Error 5.2

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever rosuvastatin or ezetimibe\], whichever came first).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=46 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=51 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis	-12.9 percent change Standard Error 2.8	-17.5 percent change Standard Error 3.1	-45.7 percent change Standard Error 2.9	-14.9 percent change Standard Error 4.2	-18.2 percent change Standard Error 4.2	-35.6 percent change Standard Error 4.3

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis	-8.3 percent change Standard Error 2.4	-8.7 percent change Standard Error 2.6	-28.9 percent change Standard Error 2.5	-8.5 percent change Standard Error 3.6	-12.4 percent change Standard Error 3.6	-20.6 percent change Standard Error 3.6

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Apo B ITT population.

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=51 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=49 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis	-8.1 percent change Standard Error 3.2	-12.1 percent change Standard Error 3.3	-36.1 percent change Standard Error 3.2	-13.7 percent change Standard Error 3.3	-14.3 percent change Standard Error 3.3	-29.0 percent change Standard Error 3.3

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Non-HDL-C ITT population.

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis	-11.7 percent change Standard Error 3.5	-16.3 percent change Standard Error 3.6	-41.2 percent change Standard Error 3.5	-18.0 percent change Standard Error 3.6	-18.7 percent change Standard Error 3.7	-29.8 percent change Standard Error 3.6

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Total-C ITT population.

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis	-8.9 percent change Standard Error 2.6	-11.8 percent change Standard Error 2.7	-29.0 percent change Standard Error 2.6	-13.8 percent change Standard Error 2.8	-13.9 percent change Standard Error 2.8	-19.4 percent change Standard Error 2.7

SECONDARY outcome

Timeframe: Up to Week 24

Population: ITT population.

Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis	45.0 percentage of participants	57.2 percentage of participants	84.9 percentage of participants	40.1 percentage of participants	52.2 percentage of participants	66.7 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: mITT population.

Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever rosuvastatin or ezetimibe\], whichever came first (on-treatment analysis).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=46 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=51 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis	47.0 percentage of participants	60.5 percentage of participants	86.4 percentage of participants	41.3 percentage of participants	54.8 percentage of participants	70.4 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: ITT population.

Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis	31.3 percentage of participants	43.1 percentage of participants	77.8 percentage of participants	29.9 percentage of participants	43.6 percentage of participants	60.1 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: mITT population.

Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever rosuvastatin or ezetimibe\], whichever came first (on-treatment analysis).

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=46 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=51 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis	34.8 percentage of participants	46.7 percentage of participants	76.5 percentage of participants	30.6 percentage of participants	45.1 percentage of participants	66.1 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Participants analyzed: participants of the ITT population.

Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis	-4.0 percent change Standard Error 4.3	-4.3 percent change Standard Error 4.5	-27.9 percent change Standard Error 4.1	-5.2 percent change Standard Error 4.8	-5.8 percent change Standard Error 4.6	-22.7 percent change Standard Error 5.1

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis	1.7 percent change Standard Error 2.4	4.0 percent change Standard Error 2.5	9.1 percent change Standard Error 2.4	1.5 percent change Standard Error 2.3	-1.8 percent change Standard Error 2.3	7.2 percent change Standard Error 2.3

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Participants analyzed: participants of the ITT population.

Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis	-1.8 percent change Standard Error 4.5	-8.3 percent change Standard Error 4.8	-11.2 percent change Standard Error 4.6	-9.9 percent change Standard Error 4.1	-11.1 percent change Standard Error 4.3	-8.7 percent change Standard Error 4.5

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=51 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=49 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis	5.4 percent change Standard Error 1.9	5.0 percent change Standard Error 1.9	6.7 percent change Standard Error 1.9	2.9 percent change Standard Error 1.9	-0.9 percent change Standard Error 1.9	6.7 percent change Standard Error 2.0

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Lipoprotein (a) ITT population.

Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis	-0.7 percent change Standard Error 3.5	-3.9 percent change Standard Error 3.6	-20.7 percent change Standard Error 3.5	3.5 percent change Standard Error 4.2	7.9 percent change Standard Error 4.1	-16.0 percent change Standard Error 4.2

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: HDL-C ITT population.

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis	0.7 percent change Standard Error 2.1	0.2 percent change Standard Error 2.2	5.9 percent change Standard Error 2.1	0.6 percent change Standard Error 2.5	3.1 percent change Standard Error 2.5	8.0 percent change Standard Error 2.5

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Fasting triglycerides ITT population.

Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=47 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=48 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=52 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=50 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=53 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis	8.1 percent change Standard Error 4.1	-8.2 percent change Standard Error 4.2	-14 percent change Standard Error 4.1	-2.7 percent change Standard Error 4.0	-12.4 percent change Standard Error 4.0	-10.1 percent change Standard Error 4.0

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Apo A-1 ITT population.

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Rosuvastatin 20 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=44 Participants Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=51 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=48 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=49 Participants Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis	4.0 percent change Standard Error 1.6	2.6 percent change Standard Error 1.6	4.3 percent change Standard Error 1.6	0.9 percent change Standard Error 1.8	1.8 percent change Standard Error 1.8	9.1 percent change Standard Error 1.8

Adverse Events

Rosuvastatin 20 mg

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Ezetimibe 10 mg + Rosuvastatin 10 mg

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Rosuvastatin 40 mg

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Ezetimibe 10 mg + Rosuvastatin 20 mg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rosuvastatin 20 mg n=48 participants at risk Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=48 participants at risk Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=49 participants at risk Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=53 participants at risk Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=53 participants at risk Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=54 participants at risk Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Cardiac disorders Acute myocardial infarction	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Cardiac disorders Angina unstable	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/54 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Cardiac disorders Arrhythmia	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/54 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Cardiac disorders Atrioventricular block second degree	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Cardiac disorders Cardiac failure congestive	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
General disorders Non-Cardiac chest pain	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Infections and infestations Spinal cord infection	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Infections and infestations Urosepsis	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.0% 1/49 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Infections and infestations Viral infection	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.0% 1/49 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.0% 1/49 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.0% 1/49 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Metabolism and nutrition disorders Obesity	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small cell lung cancer metastatic	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Nervous system disorders Haemorrhagic stroke	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Nervous system disorders Paraesthesia	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Nervous system disorders Syncope	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/54 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Psychiatric disorders Psychotic disorder	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/54 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Renal and urinary disorders Haematuria	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.

Other adverse events

Other adverse events
Measure	Rosuvastatin 20 mg n=48 participants at risk Participants who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg once daily (QD), placebo for alirocumab every 2 weeks (Q2W), and placebo for ezetimibe QD added to stable lipid-modifying therapy (LMT) for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 10 mg n=48 participants at risk Participants who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg n=49 participants at risk Participants who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.	Rosuvastatin 40 mg n=53 participants at risk Participants who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.	Ezetimibe 10 mg + Rosuvastatin 20 mg n=53 participants at risk Participants who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.	Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg n=54 participants at risk Participants who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Gastrointestinal disorders Nausea	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.1% 1/48 • Number of events 3 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	6.1% 3/49 • Number of events 3 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Infections and infestations Nasopharyngitis	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	4.2% 2/48 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	4.1% 2/49 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	11.3% 6/53 • Number of events 6 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	5.7% 3/53 • Number of events 3 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	3.7% 2/54 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Infections and infestations Upper respiratory tract infection	6.2% 3/48 • Number of events 3 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	4.1% 2/49 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	11.3% 6/53 • Number of events 7 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	7.5% 4/53 • Number of events 4 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	7.4% 4/54 • Number of events 4 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	8.2% 4/49 • Number of events 4 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	3.8% 2/53 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Musculoskeletal and connective tissue disorders Myalgia	2.1% 1/48 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	6.2% 3/48 • Number of events 3 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	7.4% 4/54 • Number of events 5 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	6.2% 3/48 • Number of events 3 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.0% 1/49 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 3/48 • Number of events 3 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	4.1% 2/49 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	9.4% 5/53 • Number of events 5 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	3.8% 2/53 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Nervous system disorders Dizziness	6.2% 3/48 • Number of events 4 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.0% 1/49 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	3.8% 2/53 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	1.9% 1/53 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	3.7% 2/54 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Nervous system disorders Headache	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.1% 1/48 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	5.7% 3/53 • Number of events 4 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/54 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	4.2% 2/48 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/49 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	5.7% 3/53 • Number of events 3 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	3.7% 2/54 • Number of events 2 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.
General disorders Injection site reaction	4.2% 2/48 • Number of events 3 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/48 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	2.0% 1/49 • Number of events 1 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	0.00% 0/53 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.	5.6% 3/54 • Number of events 5 • From Baseline to Week 32 Treatment emergent adverse events that developed during on-treatment period (the time period from the first double-blind injection of study drug up to the day of last injection + 70 days) are reported.

Additional Information

Clinical Trial Management

Regeneron Pharmaceuticals

Email: [email protected]

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