Study of the Efficacy and Safety of Alirocumab (REGN727/S... | NCT01730040

Name	Class
Sanofi	INDUSTRY

Study of the Efficacy and Safety of Alirocumab (REGN727/S... | NCT01730040 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atorvastatin 40 mg	Active Comparator	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.	Drug: Atorvastatin Drug: Placebo
Ezetimibe 10 mg + Atorvastatin 20 mg	Active Comparator	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.	Drug: Atorvastatin Drug: Ezetimibe Drug: Placebo
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Experimental	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.	Drug: Alirocumab Drug: Atorvastatin Drug: Placebo
Atorvastatin 80 mg	Active Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alirocumab	Drug	Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.	Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis	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).	From Baseline to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis	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 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34298554	Derived	Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.
30183102

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Randomized but not treated		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG0051 subjects FG0060 subjects
Subject moved		FG0000 subjects FG0010 subjects FG0021 subjects FG0030 subjects FG004
Physician Decision		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Other than specified		FG0007 subjects FG0018 subjects FG0025 subjects FG0035 subjects FG004
Adverse Event		FG0004 subjects FG0013 subjects FG0025 subjects FG0033 subjects FG004
Poor compliance to protocol		FG0002 subjects FG0014 subjects FG0020 subjects FG0030 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
BG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
BG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.
BG003	Atorvastatin 80 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
BG004	Rosuvastatin 40 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
BG005	Ezetimibe 10 mg + Atorvastatin 40 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
BG006	Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.
BG007	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063± 9.91 BG00165.7± 8.96 BG00262.2± 10.03 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022 BG00124 BG002

Low density lipoprotein cholesterol (LDL-C) in mg/dL

Calculated LDL-C from Friedewald formula.

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000100.3± 29.8 BG001100.4± 29.5

LDL-C in mmol/L

Calculated LDL-C from Friedewald formula.

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0002.957± 0.773 BG0012.599± 0.765 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis

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).

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

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.
OG003	Atorvastatin 80 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
OG004	Rosuvastatin 40 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
OG005	Ezetimibe 10 mg + Atorvastatin 40 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG006	Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.

Units	Counts
Participants	OG00053 OG00153 OG00255 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-5± 4.6 OG001-20.5± 4.7 OG002-44.1± 4.5 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.	Mixed Models Analysis	Threshold for significance ≤ 0.01.	< 0.0001		LS Mean Difference	-39.1			2-Sided	99	-55.9	-22.2				No	Superiority or Other
OG001 OG002

Secondary

Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

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 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).

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

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.

Secondary

Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

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).

ITT population.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis

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 atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).

mITT population.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002

Secondary

Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis

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.

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

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis

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 atorvastatin, rosuvastatin or ezetimibe], whichever came first).

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

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002

Secondary

Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis

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.

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

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis

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 atorvastatin, rosuvastatin or ezetimibe], whichever came first).

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

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002

Secondary

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis

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.

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

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percent Change From Baseline in Apo B at Week 12 - ITT Analysis

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.

Apo B ITT population.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.

Secondary

Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis

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.

Non-HDL-C ITT population.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.

Secondary

Percent Change From Baseline in Total-C at Week 12 - ITT Analysis

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.

Total-C ITT population.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.

Secondary

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

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).

ITT population.

Posted

Number

percentage of participants

Up to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

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 atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).

mITT population.

Posted

Number

percentage of participants

Up to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.

Secondary

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis

ITT population.

Posted

Number

percentage of participants

Up to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis

mITT population.

Posted

Number

percentage of participants

Up to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis

Adjusted means and standard errors at Week 24 from 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.

Participants analyzed: participants of the ITT population.

Posted

Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis

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.

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

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis

ITT population: all randomized and treated participants with one baseline and at least one post-baseline fasting triglycerides value on- or off-treatment.

Posted

Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis

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.

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

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg

Secondary

Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis

Adjusted means and standard errors at Week 12 from 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.

Lipoprotein (a) ITT population.

Posted

Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.

Secondary

Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis

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.

HDL-C ITT population.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.

Secondary

Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis

ITT population.

Posted

Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.

Secondary

Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis

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.

Apo A-1 ITT population.

Posted

Least Squares Mean

Standard Error

percent change

From Baseline to Week 24

ID	Title	Description
OG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
OG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
OG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Atorvastatin 40 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.	2	57	17	57
EG001	Ezetimibe 10 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.	5	55	24	55
EG002	Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg	Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.	3	57	15	57
EG003	Atorvastatin 80 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.	4	47	18	47
EG004	Rosuvastatin 40 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.	2	45	23	45
EG005	Ezetimibe 10 mg + Atorvastatin 40 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection.Q2W added to stable LMT for 24 weeks.	2	46	12	46
EG006	Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg	Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.	1	47	19	47

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0022 events2 affected57 at risk EG0030 events0 affected47 at risk EG0040 events0 affected45 at risk EG0050 events0 affected46 at risk EG0060 events0 affected47 at risk
Atrioventricular block complete	Cardiac disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003
Cardiac arrest	Cardiac disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0020 events0 affected57 at risk EG003
Coronary artery disease	Cardiac disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003
Chest pain	General disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0020 events0 affected57 at risk EG003
Non-Cardiac chest pain	General disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0020 events0 affected57 at risk EG003
Diverticulitis	Infections and infestations	meddra (17.0)	Systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003
Pneumonia	Infections and infestations	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0020 events0 affected57 at risk EG003
Seroma	Injury, poisoning and procedural complications	meddra (17.0)	Systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0021 events1 affected57 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003
Dizziness	Nervous system disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0020 events0 affected57 at risk EG003
Anxiety	Psychiatric disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0020 events0 affected57 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0020 events0 affected57 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003
Aortic aneurysm	Vascular disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	meddra (17.0)	Systematic Assessment	EG0004 events4 affected57 at risk EG0011 events1 affected55 at risk EG0021 events1 affected57 at risk EG0031 events1 affected47 at risk EG0046 events3 affected45 at risk EG0053 events2 affected46 at risk EG0061 events1 affected47 at risk
Nausea	Gastrointestinal disorders	meddra (17.0)	Systematic Assessment	EG0003 events3 affected57 at risk EG0013 events3 affected55 at risk EG0021 events1 affected57 at risk EG003
Fatigue	General disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected55 at risk EG0020 events0 affected57 at risk EG003
Influenza	Infections and infestations	meddra (17.0)	Systematic Assessment	EG0001 events1 affected57 at risk EG0011 events1 affected55 at risk EG0021 events1 affected57 at risk EG003
Nasopharyngitis	Infections and infestations	meddra (17.0)	Systematic Assessment	EG0001 events1 affected57 at risk EG0013 events3 affected55 at risk EG0021 events1 affected57 at risk EG003
Upper respiratory tract infection	Infections and infestations	meddra (17.0)	Systematic Assessment	EG0003 events2 affected57 at risk EG0014 events4 affected55 at risk EG0022 events2 affected57 at risk EG003
Urinary tract infection	Infections and infestations	meddra (17.0)	Systematic Assessment	EG0003 events3 affected57 at risk EG0016 events5 affected55 at risk EG0021 events1 affected57 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	meddra (17.0)	Systematic Assessment	EG0003 events2 affected57 at risk EG0012 events2 affected55 at risk EG0020 events0 affected57 at risk EG003
Contusion	Injury, poisoning and procedural complications	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0015 events1 affected55 at risk EG0020 events0 affected57 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	meddra (17.0)	Systematic Assessment	EG0003 events3 affected57 at risk EG0013 events3 affected55 at risk EG0020 events0 affected57 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0020 events0 affected57 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	meddra (17.0)	Systematic Assessment	EG0001 events1 affected57 at risk EG0014 events3 affected55 at risk EG0023 events2 affected57 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	meddra (17.0)	Systematic Assessment	EG0002 events2 affected57 at risk EG0013 events3 affected55 at risk EG0023 events3 affected57 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0026 events4 affected57 at risk EG003
Dizziness	Nervous system disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0012 events2 affected55 at risk EG0020 events0 affected57 at risk EG003
Hypertension	Vascular disorders	meddra (17.0)	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected55 at risk EG0022 events2 affected57 at risk EG003

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids
D001384	Azetidines
D001385	Azetines
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1% level.	Mixed Models Analysis		< 0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-42.5	2-Sided	99	-59.2	-25.7	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis		= 0.0002	Threshold for significance≤ 0.01.	LS Mean Difference	-24.9	2-Sided	99	-41.9	-7.8	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis		< 0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-52.8	2-Sided	99	-69.2	-36.5	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	Threshold for significance ≤ 0.01.	< 0.0001		LS Mean Difference	-35.0	2-Sided	99	-51.3	-18.6	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis		< 0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-33.4	2-Sided	99	-50.0	-16.8	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-39.8	2-Sided	99	-54	-25.6	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-25.8	2-Sided	99	-40.0	-11.6	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-36.0	2-Sided	99	-47.7	-24.3	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-27.3	2-Sided	99	-39.2	-15.4	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-20.9	2-Sided	99	-32.8	-8.9	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-44.5	2-Sided	99	-55.8	-33.1	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-26.6	2-Sided	99	-38.0	-15.2	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-36.3	2-Sided	99	-48.1	-24.5	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-27.7	2-Sided	99	-39.6	-15.8	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-20.2	2-Sided	99	-32.2	-8.2	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-29.3	2-Sided	99	-42.0	-16.6	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-23.6	2-Sided	99	-36.6	-10.7	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-38.4	2-Sided	99	-50.8	-26.0	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-30.9	2-Sided	99	-43.2	-18.6	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-27.6	2-Sided	99	-40.1	-15.1	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-32.6	2-Sided	99	-44.6	-20.6	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-25.1	2-Sided	99	-37.3	-12.8	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-38.3	2-Sided	99	-51.2	-25.4	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-29.8	2-Sided	99	-42.6	-17.1	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-26.4	2-Sided	99	-39.4	-13.4	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-30.4	2-Sided	99	-44.7	-16.1	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	=0.0002	Threshold for significance ≤ 0.01.	LS Mean Difference	-21.6	2-Sided	99	-36.1	-7.1	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-41.1	2-Sided	99	-54.7	-27.5	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-30.2	2-Sided	99	-43.7	-16.6	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-26.6	2-Sided	99	-40.3	-12.8	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-33.0	2-Sided	99	-47.0	-19.0	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-22.4	2-Sided	99	-36.6	-8.1	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-43.6	2-Sided	99	-57.4	-29.7	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-32.1	2-Sided	99	-46.0	-18.3	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-27.3	2-Sided	99	-41.4	-13.2	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-23.1	2-Sided	99	-32.9	-13.2	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-15.8	2-Sided	99	-25.8	-5.8	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-28.9	2-Sided	99	-39.4	-18.4	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-21.9	2-Sided	99	-32.4	-11.4	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-18.4	2-Sided	99	-29.1	-7.7	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-31.5	2-Sided	99	-41.6	-21.3	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-25.3	2-Sided	99	-35.4	-15.2	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-26.7	2-Sided	99	-35.9	-17.5	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-22.2	2-Sided	99	-31.5	-12.9	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-15.9	2-Sided	99	-25.2	-6.6	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-33.5	2-Sided	99	-45.3	-21.6	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-23.4	2-Sided	99	-35.2	-11.6	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-29.3	2-Sided	99	-39.0	-19.6	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-22.5	2-Sided	99	-32.3	-12.7	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-14.8	2-Sided	99	-24.7	-4.9	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-22.6	2-Sided	99	-31.4	-13.8	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-15.8	2-Sided	99	-24.6	-7.0	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-19.1	2-Sided	99	-26.9	-11.4	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	<0.0001	Threshold for significance ≤ 0.01.	LS Mean Difference	-15.4	2-Sided	99	-23.3	-7.6	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Mixed Models Analysis	=0.0015	Threshold for significance ≤ 0.01.	LS Mean Difference	-9.8	2-Sided	99	-17.7	-1.9	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.	Regression, Logistic	<0.0001	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	16.7	2-Sided	99	3.9	71.7	No	Superiority or Other
OG001 OG002	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	=0.0284	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	3.4	2-Sided	99	0.8	14.6	No	Superiority or Other
OG003 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	<0.0001	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	83.2	2-Sided	99	11.6	596.8	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	=0.0025	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	7.2	2-Sided	99	1.3	38.3	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	=0.0011	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	9.1	2-Sided	99	1.6	52.2	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG003 OG006	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.	Regression, Logistic	<0.0001	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	128.4	2-Sided	99	14.2	1157	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	=0.0015	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	10.9	2-Sided	99	1.6	75.4	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	=0.0008	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	13.7	2-Sided	99	1.8	101.1	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG003 OG006	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.	Regression, Logistic	<0.0001	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	116.8	2-Sided	99	14.7	927.5	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	<0.0001	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	13.2	2-Sided	99	2.5	68.8	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	=0.0004	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	9.9	2-Sided	99	1.9	51.9	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG003 OG006	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.	Regression, Logistic	<0.0001	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	162.1	2-Sided	99	17.3	1520.5	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	<0.0001	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	19.8	2-Sided	99	3.1	126.3	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Logistic	=0.0002	Threshold for significance ≤ 0.01.	Odds Ratio (OR)	13.9	2-Sided	99	2.2	88.1	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG003 OG006	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.	Regression, Robust	=0.0004	Threshold for significance ≤ 0.01.	Adjusted Mean Difference	-21.1	2-Sided	99	-36.3	-5.9	No	Superiority or Other
OG004 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Robust	<0.0001	Threshold for significance ≤ 0.01.	Adjusted Mean Difference	-25.9	2-Sided	99	-40.2	-11.6	No	Superiority or Other
OG005 OG006	Analysis description as per the statistical analysis 1 of this endpoint.	Regression, Robust	<0.0001	Threshold for significance ≤ 0.01.	Adjusted Mean Difference	-31.0	2-Sided	99	-45.6	-16.4	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG003 OG006	Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification).	Mixed Models Analysis		=0.4456	Threshold for significance ≤ 0.01.	LS Mean Difference	2.9			2-Sided	99	-7.0	12.9				No	Superiority or Other

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama		United States

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C571059	alirocumab
D000069059	Atorvastatin
D000069438	Ezetimibe
D000068718	Rosuvastatin Calcium