## Protocol Section
### Identification Module
**NCT ID:** NCT02023879

**Brief Title:** Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

**Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin

#### Organization Study ID Info
**ID:** EFC13786
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**ID:** 2013-002659-14
**Type:** EUDRACT_NUMBER
**Domain:** UTN
**ID:** U1111-1146-3517
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2017-06-30

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2015-11-01

**Type:** ESTIMATED

**Disp First Submit Date:** 2015-10-08
**Disp First Submit QC Date:** 2015-10-08

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-07-27

**Type:** ACTUAL

**Last Update Submit Date:** 2018-06-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-10-27

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-03-15

**Type:** ACTUAL

**Results First Submit Date:** 2017-01-24

**Results First Submit QC Date:** 2017-01-24

#### Start Date
**Date:** 2013-12-16

**Status Verified Date:** 2018-06

#### Study First Post Date
**Date:** 2013-12-30
**Type:** ESTIMATED
**Study First Submit Date:** 2013-12-06
**Study First Submit QC Date:** 2013-12-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Regeneron Pharmaceuticals

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sanofi

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin.

Secondary Objective:

* To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo.
* To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.

Alirocumab 75 mg Q2W was added as a calibrator arm.

**Detailed Description:** The core study duration was approximately 35 weeks per participant (screening: 3 weeks, double-blind treatment period: 24 weeks; follow-up: 8 weeks). Participants who successfully completed the treatment period had the possibility to participate in an optional open-label treatment period with Alirocumab 150 mg Q4W until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first.

### Conditions Module

**Conditions:**

- Hypercholesterolemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** A double-blind treatment period of 24 weeks (3 parallel arms) followed by an open-label extension period (single arm)

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** Masking during the double-blind treatment period

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 233

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.

Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.

**Intervention Names:**

- Drug: Alirocumab

- Drug: Placebo (for Alirocumab)

- Drug: Non-statin LMT

- Other: Diet Alone

**Label:** Placebo Q2W

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.

Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.

**Intervention Names:**

- Drug: Alirocumab

- Drug: Non-statin LMT

- Other: Diet Alone

**Label:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)

**Type:** OTHER

#### Arm Group 3

**Description:** Period 1: Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.

Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.

**Intervention Names:**

- Drug: Alirocumab

- Drug: Placebo (for Alirocumab)

- Drug: Non-statin LMT

- Other: Diet Alone

**Label:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Alirocumab 150 mg Q4W/Up to 150 mg Q2W

- Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)

- Placebo Q2W

**Description:** Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).

**Name:** Alirocumab

**Other Names:**

- SAR236553

- REGN727

- Praluent®

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Alirocumab 150 mg Q4W/Up to 150 mg Q2W

- Placebo Q2W

**Description:** Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).

**Name:** Placebo (for Alirocumab)

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Alirocumab 150 mg Q4W/Up to 150 mg Q2W

- Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)

- Placebo Q2W

**Description:** Ezetimibe or Fenofibrate at stable dose as background therapy.

**Name:** Non-statin LMT

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Alirocumab 150 mg Q4W/Up to 150 mg Q2W

- Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)

- Placebo Q2W

**Description:** Stable cholesterol-lowering diet as background therapy.

**Name:** Diet Alone

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Mean percent changes (and standard deviations) observed during the open-label extension period are provided.

**Measure:** Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase

**Time Frame:** Baseline, Week 32, 36, 48, 72, 96, 120, 144 and Week 168

#### Primary Outcomes

**Description:** 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).

**Measure:** Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)

**Time Frame:** From Baseline to Week 24

#### Secondary Outcomes

**Description:** Adjusted LS means and standard errors at Week 24 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) (on-treatment analysis).

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

**Description:** Adjusted LS means and standard errors at Week 12 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).

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

**Time Frame:** From Baseline to Week 24

**Description:** Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.

**Measure:** Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 - ITT- Analysis

**Time Frame:** From Baseline to Week 24

**Description:** Adjusted LS means and standard errors at Week 12 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) and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.

**Measure:** Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

**Description:** Adjusted LS means and standard errors at Week 24 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).

**Measure:** Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis

**Time Frame:** From Baseline to Week 24

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

**Measure:** Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis

**Time Frame:** From Baseline to Week 24

**Description:** Adjusted LS means and standard errors at Week 24 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).

**Measure:** Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis

**Time Frame:** From Baseline to Week 24

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

**Measure:** Percent Change From Baseline in Total-C at Week 24 - ITT Analysis

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

**Description:** Moderate CV risk: 10-year fatal cardiovascular disease (CVD) risk Systemic Coronary Risk Evaluation (SCORE) ≥1 and \<5%.

High CV risk: 10-year fatal CVD risk SCORE ≥5% or moderate chronic kidney disease or type 1 or type 2 diabetes mellitus without target organ damage or familial hypercholesterolemia.

Very high CV risk: history of documented coronary heart disease, ischemic stroke, peripheral artery disease, transient ischemic attack, abdominal aortic aneurysm, or carotid artery occlusion \>50% without symptoms; carotid endarterectomy or carotid artery stent procedure; renal artery stenosis, or renal artery stent procedure; or type 1 or type 2 diabetes mellitus with target organ damage.

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.

**Measure:** Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis

**Time Frame:** From Baseline to Week 24

**Description:** Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

**Measure:** Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 - On-treatment Analysis

**Time Frame:** From Baseline to Week 24

**Description:** Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

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

**Time Frame:** From Baseline to Week 24

**Description:** Adjusted percentages at Week 24 from LOCF approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

**Measure:** Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 - On-treatment Analysis

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

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

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

**Time Frame:** From Baseline to Week 24

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

Participants with primary hypercholesterolemia (heterozygous familial hypercholesterolemia \[heFH\] or non-FH) not adequately controlled with their non-statin LMT (either ezetimibe or fenofibrate) or diet alone.

Exclusion criteria:

* LDL-C \<70 mg/dL (1.81 mmol/L) at screening for statin intolerant participants at very high cardiovascular (CV) risk;
* LDL-C \<100 mg/dL (\<2.59 mmol/L) at screening for statin intolerant participants at high or moderate CV risk or, participants not fulfilling the statin intolerant definition at moderate CV risk;
* LDL-C ≥160 mg/dL (≥4.1 mmol/L) at screening for participants receiving diet only or, participants not fulfilling the statin intolerant definition at moderate CV risk and receiving a non-statin LMT.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beverly Hills

**Country:** United States

**Facility:** Investigational Site Number 840703

**State:** California

**Zip:** 90211

**Location 2:**

**City:** Atlantis

**Country:** United States

**Facility:** Investigational Site Number 840704

**State:** Florida

**Zip:** 33462

**Location 3:**

**City:** Jacksonville

**Country:** United States

**Facility:** Investigational Site Number 840708

**State:** Florida

**Zip:** 32216

**Location 4:**

**City:** Sarasota

**Country:** United States

**Facility:** Investigational Site Number 840701

**State:** Florida

**Zip:** 34239

**Location 5:**

**City:** Fall River

**Country:** United States

**Facility:** Investigational Site Number 840706

**State:** Massachusetts

**Zip:** 02720

**Location 6:**

**City:** Saint Louis

**Country:** United States

**Facility:** Investigational Site Number 840705

**State:** Missouri

**Zip:** 63131

**Location 7:**

**City:** Durham

**Country:** United States

**Facility:** Investigational Site Number 840707

**State:** North Carolina

**Zip:** 27710

**Location 8:**

**City:** Summerville

**Country:** United States

**Facility:** Investigational Site Number 840702

**State:** South Carolina

**Zip:** 29485

**Location 9:**

**City:** Ashford

**Country:** Australia

**Facility:** Investigational Site Number 036703

**Zip:** 5035

**Location 10:**

**City:** Perth

**Country:** Australia

**Facility:** Investigational Site Number 036702

**Zip:** 6000

**Location 11:**

**City:** Woolloongabba

**Country:** Australia

**Facility:** Investigational Site Number 036701

**Zip:** 4102

**Location 12:**

**City:** Antwerpen

**Country:** Belgium

**Facility:** Investigational Site Number 056702

**Zip:** 2060

**Location 13:**

**City:** Haine-Saint-Paul

**Country:** Belgium

**Facility:** Investigational Site Number 056703

**Zip:** 7100

**Location 14:**

**City:** Leuven

**Country:** Belgium

**Facility:** Investigational Site Number 056701

**Zip:** 3000

**Location 15:**

**City:** Chicoutimi

**Country:** Canada

**Facility:** Investigational Site Number 124703

**Zip:** G7H 7P2

**Location 16:**

**City:** Quebec

**Country:** Canada

**Facility:** Investigational Site Number 124701

**Zip:** G1V 4M6

**Location 17:**

**City:** Sherbrooke

**Country:** Canada

**Facility:** Investigational Site Number 124704

**Zip:** J1H 1Z1

**Location 18:**

**City:** Toronto

**Country:** Canada

**Facility:** Investigational Site Number 124706

**Zip:** M9V 4B4

**Location 19:**

**City:** Vancouver

**Country:** Canada

**Facility:** Investigational Site Number 124702

**Zip:** V5Z 1M9

**Location 20:**

**City:** Victoria

**Country:** Canada

**Facility:** Investigational Site Number 124705

**Zip:** V8T 5G4

**Location 21:**

**City:** Aarhus

**Country:** Denmark

**Facility:** Investigational Site Number 208703

**Zip:** 8200

**Location 22:**

**City:** Esbjerg

**Country:** Denmark

**Facility:** Investigational Site Number 208702

**Zip:** 6700

**Location 23:**

**City:** Glostrup

**Country:** Denmark

**Facility:** Investigational Site Number 208701

**Zip:** 2600

**Location 24:**

**City:** Hvidovre

**Country:** Denmark

**Facility:** Investigational Site Number 208704

**Zip:** 2650

**Location 25:**

**City:** Køge

**Country:** Denmark

**Facility:** Investigational Site Number 208705

**Zip:** 4600

**Location 26:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Investigational Site Number 528701

**Zip:** 1105 AZ

**Location 27:**

**City:** Den Helder

**Country:** Netherlands

**Facility:** Investigational Site Number 528708

**Zip:** 1782 GZ

**Location 28:**

**City:** Hoogeveen

**Country:** Netherlands

**Facility:** Investigational Site Number 528702

**Zip:** 7909 AA

**Location 29:**

**City:** Hoorn

**Country:** Netherlands

**Facility:** Investigational Site Number 528703

**Zip:** 1625 HV

**Location 30:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Investigational Site Number 528706

**Zip:** 3045 PM

**Location 31:**

**City:** Sneek

**Country:** Netherlands

**Facility:** Investigational Site Number 528709

**Zip:** 8601 ZK

**Location 32:**

**City:** Utrecht

**Country:** Netherlands

**Facility:** Investigational Site Number 528704

**Zip:** 3584 CX

**Location 33:**

**City:** Venlo

**Country:** Netherlands

**Facility:** Investigational Site Number 528707

**Zip:** 5912 BL

**Location 34:**

**City:** Auckland

**Country:** New Zealand

**Facility:** Investigational Site Number 554702

**Zip:** 1023

**Location 35:**

**City:** Christchurch

**Country:** New Zealand

**Facility:** Investigational Site Number 554701

**Zip:** 8011

**Location 36:**

**City:** A Coruna

**Country:** Spain

**Facility:** Investigational Site Number 724703

**Zip:** 15006

**Location 37:**

**City:** Barcelona

**Country:** Spain

**Facility:** Investigational Site Number 724707

**Zip:** 08025

**Location 38:**

**City:** Barcelona

**Country:** Spain

**Facility:** Investigational Site Number 724710

**Zip:** 08035

**Location 39:**

**City:** Córdoba

**Country:** Spain

**Facility:** Investigational Site Number 724702

**Zip:** 14004

**Location 40:**

**City:** Granada

**Country:** Spain

**Facility:** Investigational Site Number 724705

**Zip:** 18012

**Location 41:**

**City:** Sant Joan Despí

**Country:** Spain

**Facility:** Investigational Site Number 724709

**Zip:** 08970

**Location 42:**

**City:** Santiago De Compostela

**Country:** Spain

**Facility:** Investigational Site Number 724706

**Zip:** 15706

**Location 43:**

**City:** Zaragoza

**Country:** Spain

**Facility:** Investigational Site Number 724701

**Zip:** 50009

#### Overall Officials

**Official 1:**

**Affiliation:** Sanofi

**Name:** Clinical Sciences & Operations

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Stroes E, Guyton JR, Lepor N, Civeira F, Gaudet D, Watts GF, Baccara-Dinet MT, Lecorps G, Manvelian G, Farnier M; ODYSSEY CHOICE II Investigators. Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study. J Am Heart Assoc. 2016 Sep 13;5(9):e003421. doi: 10.1161/JAHA.116.003421.

**PMID:** 27625344

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006949

- Term: Hyperlipidemias

- ID: D000050171

- Term: Dyslipidemias

- ID: D000052439

- Term: Lipid Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9988

- Name: Hypercholesterolemia

- Relevance: HIGH

- As Found: Hypercholesterolemia

- ID: M10000

- Name: Hyperlipidemias

- Relevance: LOW

- As Found: Unknown

- ID: M10002

- Name: Hyperlipoproteinemias

- Relevance: LOW

- As Found: Unknown

- ID: M26181

- Name: Dyslipidemias

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27029

- Name: Lipid Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006937

- Term: Hypercholesterolemia

### Intervention Browse Module - Ancestors

- ID: D000091362

- Term: PCSK9 Inhibitors

- ID: D000000924

- Term: Anticholesteremic Agents

- ID: D000000960

- Term: Hypolipidemic Agents

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000015842

- Term: Serine Proteinase Inhibitors

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000057847

- Term: Lipid Regulating Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M347350

- Name: Alirocumab

- Relevance: HIGH

- As Found: Testicular

- ID: M409

- Name: Ezetimibe

- Relevance: LOW

- As Found: Unknown

- ID: M14218

- Name: Fenofibrate

- Relevance: LOW

- As Found: Unknown

- ID: M21155

- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: HIGH

- As Found: Testicular

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M2849

- Name: PCSK9 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4243

- Name: Anticholesteremic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4278

- Name: Hypolipidemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M18391

- Name: Serine Proteinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M28883

- Name: Lipid Regulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: T18

- Name: Serine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000571059

- Term: Alirocumab

- ID: D000000911

- Term: Antibodies, Monoclonal

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.

#### Event Groups

**Group ID:** EG000

**Title:** Placebo Q2W

**Deaths Num At Risk:** 58

**Description:** Participants exposed to placebo SC injection Q2W added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).

**ID:** EG000

**Other Num Affected:** 28

**Other Num at Risk:** 58

**Serious Number Affected:** 4

**Serious Number At Risk:** 58

**Title:** Placebo Q2W

**Group ID:** EG001

**Title:** Alirocumab 75 mg Q2W/Up150 mg Q2W

**Deaths Num At Risk:** 115

**Description:** Participants exposed to alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).

**ID:** EG001

**Other Num Affected:** 61

**Other Num at Risk:** 115

**Serious Number Affected:** 7

**Serious Number At Risk:** 115

**Title:** Alirocumab 75 mg Q2W/Up150 mg Q2W

**Group ID:** EG002

**Title:** Alirocumab 150 mg Q4W/Up150 mg Q2W

**Deaths Num At Risk:** 58

**Description:** Participants exposed to alirocumab 150 mg Q4W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 22 weeks).

**ID:** EG002

**Other Num Affected:** 29

**Other Num at Risk:** 58

**Serious Number Affected:** 7

**Serious Number At Risk:** 58

**Title:** Alirocumab 150 mg Q4W/Up150 mg Q2W

**Group ID:** EG003

**Title:** Alirocumab 150 mg Q4W (After Placebo Q2W)

**Deaths Num At Risk:** 51

**Description:** Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 128 weeks) after having received Placebo Q2W for 24 weeks.

**ID:** EG003

**Other Num Affected:** 42

**Other Num at Risk:** 51

**Serious Number Affected:** 15

**Serious Number At Risk:** 51

**Title:** Alirocumab 150 mg Q4W (After Placebo Q2W)

**Group ID:** EG004

**Title:** Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)

**Deaths Num Affected:** 2

**Deaths Num At Risk:** 106

**Description:** Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 117 weeks) after having received Alirocumab 75 mg Q2W/Up to 150 mg Q2W for 24 weeks.

**ID:** EG004

**Other Num Affected:** 71

**Other Num at Risk:** 106

**Serious Number Affected:** 28

**Serious Number At Risk:** 106

**Title:** Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)

**Group ID:** EG005

**Title:** Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 48

**Description:** Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 119 weeks) after having received Alirocumab 150 mg Q4W/Up to 150 mg Q2W for 24 weeks.

**ID:** EG005

**Other Num Affected:** 31

**Other Num at Risk:** 48

**Serious Number Affected:** 14

**Serious Number At Risk:** 48

**Title:** Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)

**Frequency Threshold:** 5

#### Other Events

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Injection site reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

**Term:** Viral upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

**Term:** Laceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

**Term:** Gout

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Hyperkalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Musculoskeletal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Dry skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 20.0

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 20.0

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Haemorrhagic anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Acute coronary syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 3

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Angina pectoris

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Angina unstable

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Aortic valve stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Cardiac failure congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 2

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Cardio-respiratory arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Cardiomyopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Coronary artery disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 2

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Mitral valve incompetence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Basedow's disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Retinal detachment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Abdominal wall haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Faecaloma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Retroperitoneal haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Small intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Volvulus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 2

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Biliary colic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Appendicitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Arthritis bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Device related infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Hepatitis E

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 2

**Num At Risk:** 48

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Craniocerebral injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Femur fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Humerus fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Intentional overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Jaw fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Multiple fractures

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Post procedural haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Radius fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Rib fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Road traffic accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Spinal fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Subdural haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Traumatic haemothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Traumatic renal injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Vascular pseudoaneurysm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Lumbar spinal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Musculoskeletal chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Rhabdomyolysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Rheumatoid arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Spinal osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Adenocarcinoma of colon

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Basal cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 2

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Benign fallopian tube neoplasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Bladder transitional cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Breast cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Meningioma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Oesophageal squamous cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Prostate cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 2

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Skin cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Uterine leiomyoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Arachnoiditis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Cerebellar infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Essential tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Hypoxic-ischaemic encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Multiple sclerosis relapse

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Presyncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 2

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 3

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 2

**Num At Risk:** 48

**Term:** Transient ischaemic attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Mental disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Suicide attempt

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Acute kidney injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Nephrolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Chronic obstructive pulmonary disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Hypertensive crisis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 2

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Hypovolaemic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Peripheral artery occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Term:** Peripheral artery stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num At Risk:** 106

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 48

**Term:** Peripheral ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 58

**Group ID:** EG001

**Num At Risk:** 115

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 51

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 106

**Group ID:** EG005

**Num At Risk:** 48

**Time Frame:** All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 58

**Group ID:** BG001

**Value:** 116

**Group ID:** BG002

**Value:** 59

**Group ID:** BG003

**Value:** 233

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo Q2W

**Description:** Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.

Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.

### Group

**ID:** BG001

**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)

**Description:** Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.

Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.

### Group

**ID:** BG002

**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W

**Description:** Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.

Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.7

**Value:** 63.1

#### Measurement

**Group ID:** BG001

**Spread:** 9.9

**Value:** 62.5

#### Measurement

**Group ID:** BG002

**Spread:** 10.0

**Value:** 64.2

#### Measurement

**Group ID:** BG003

**Spread:** 10.1

**Value:** 63.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 27

#### Measurement

**Group ID:** BG001

**Value:** 47

#### Measurement

**Group ID:** BG002

**Value:** 29

#### Measurement

**Group ID:** BG003

**Value:** 103

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 69

#### Measurement

**Group ID:** BG002

**Value:** 30

#### Measurement

**Group ID:** BG003

**Value:** 130

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 12

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 57

#### Measurement

**Group ID:** BG001

**Value:** 109

#### Measurement

**Group ID:** BG002

**Value:** 54

#### Measurement

**Group ID:** BG003

**Value:** 220

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 8

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 5

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 56

#### Measurement

**Group ID:** BG001

**Value:** 108

#### Measurement

**Group ID:** BG002

**Value:** 55

#### Measurement

**Group ID:** BG003

**Value:** 219

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 47.3

**Value:** 158.5

#### Measurement

**Group ID:** BG001

**Spread:** 44.6

**Value:** 154.5

#### Measurement

**Group ID:** BG002

**Spread:** 69.1

**Value:** 163.9

#### Measurement

**Group ID:** BG003

**Spread:** 52.4

**Value:** 157.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.226

**Value:** 4.106

#### Measurement

**Group ID:** BG001

**Spread:** 1.154

**Value:** 4.002

#### Measurement

**Group ID:** BG002

**Spread:** 1.789

**Value:** 4.245

#### Measurement

**Group ID:** BG003

**Spread:** 1.356

**Value:** 4.089

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Description:** Calculated LDL-C from Friedewald formula (LDL-C = Total cholesterol \[Total-C\] - High-Density Lipoprotein Cholesterol \[HDL-C\] - \[Triglyceride/5\]).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Calculated LDL-C in mg/dL
**Unit of Measure:** mg/dL
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Calculated LDL-C in mmol/L
**Unit of Measure:** mmol/L
## Results Section - More Information Module
### Certain Agreement
**Other Details:** If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** The systematic randomization error was not anticipated to have an impact on the power of the study. The sample size to detect a difference in efficacy endpoints was reached (it was increased to obtain additional safety data) and blind was maintained.
### Point of Contact
**Email:** Contact-US@sanofi.com
**Organization:** Sanofi
**Title:** Trial Transparency Team
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -62.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -49.9
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Alirocumab 150 mg Q4W/up to 150 mg Q2W was compared to placebo group using an appropriate contrast statement.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** Least square (LS) mean difference
**Parameter Value:** -56.4
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -65.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -53.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** 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 0.05 level.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -59.7
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -51.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -38.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -44.9
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -54.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -41.9
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -48.4
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -61.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -49.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -55.5
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -63.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -53.4
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -58.6
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** -52.4
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -40.4
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -46.4
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -54.3
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -42.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -48.6
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** -54.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -43.2
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -49.0
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 10
#### Analysis
**CI Lower Limit:** -57.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -46.4
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -51.7
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** -39.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -30.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -35.3
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 12
#### Analysis
**CI Lower Limit:** -44.3
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -32.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -38.2
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** -43.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -31.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -37.9
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 14
#### Analysis
**CI Lower Limit:** -30.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -21.7
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -26.3
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 15
#### Analysis
**CI Lower Limit:** 29.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2690.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 279.8
**Statistical Comment:** Multiple imputation approach followed by logistic regression model.
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
### Outcome Measure 16
#### Analysis
**CI Lower Limit:** 36.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3479.5
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 354.7
**Statistical Comment:** Multiple imputation approach followed by logistic regression model.
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
### Outcome Measure 17
#### Analysis
**CI Lower Limit:** 20.0
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 9999
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 126.0
**Statistical Comment:** LOCF approach followed by logistic regression model.
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
### Outcome Measure 18
#### Analysis
**CI Lower Limit:** 22.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 9999
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 141.5
**Statistical Comment:** LOCF approach followed by logistic regression model.
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
### Outcome Measure 19
#### Analysis
**CI Lower Limit:** -29.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -9.4
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0002
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** Adjusted mean difference
**Parameter Value:** -19.6
**Statistical Comment:** Multiple imputation approach followed by robust regression model.
**Statistical Method:** Regression, Robust
**Tested Non-Inferiority:** 
### Outcome Measure 20
#### Analysis
**CI Lower Limit:** -17.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.2
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
**Group Description:** Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0892
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** Adjusted mean difference
**Parameter Value:** -7.9
**Statistical Comment:** Multiple imputation approach followed by robust regression model.
**Statistical Method:** Regression, Robust
**Tested Non-Inferiority:** 
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
### Outcome Measure 24
### Outcome Measure 25
### Outcome Measure 26
### Outcome Measure 27
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.3
- **Upper Limit:** 
- **Value:** 4.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** -53.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.3
- **Upper Limit:** 
- **Value:** -51.7
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** 5.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.5
- **Upper Limit:** 
- **Value:** -55.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** -54.6
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.5
- **Upper Limit:** 
- **Value:** 3.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.7
- **Upper Limit:** 
- **Value:** -50.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.4
- **Upper Limit:** 
- **Value:** -41.7
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.3
- **Upper Limit:** 
- **Value:** 3.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** -51.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.3
- **Upper Limit:** 
- **Value:** -44.8
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.0
- **Upper Limit:** 
- **Value:** 3.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.4
- **Upper Limit:** 
- **Value:** -53.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.0
- **Upper Limit:** 
- **Value:** -52.3
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** 3.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.3
- **Upper Limit:** 
- **Value:** -54.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -55.0
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** 7.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.5
- **Upper Limit:** 
- **Value:** -39.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.2
- **Upper Limit:** 
- **Value:** -38.9
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.0
- **Upper Limit:** 
- **Value:** 7.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.4
- **Upper Limit:** 
- **Value:** -41.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** -40.9
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** 4.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.5
- **Upper Limit:** 
- **Value:** -45.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** -44.2
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** 5.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.3
- **Upper Limit:** 
- **Value:** -46.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -46.7
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** 3.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.1
- **Upper Limit:** 
- **Value:** -34.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** -32.3
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.2
- **Upper Limit:** 
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** -38.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.2
- **Upper Limit:** 
- **Value:** -31.3
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.2
- **Upper Limit:** 
- **Value:** 3.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.5
- **Upper Limit:** 
- **Value:** -43.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.2
- **Upper Limit:** 
- **Value:** -34.9
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** 1.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.2
- **Upper Limit:** 
- **Value:** -32.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** -24.5
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63.9
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67.7
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 60.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.9
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.7
- **Upper Limit:** 
- **Value:** 4.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.6
- **Upper Limit:** 
- **Value:** -21.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.7
- **Upper Limit:** 
- **Value:** -15.5
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.4
- **Upper Limit:** 
- **Value:** 2.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.4
- **Upper Limit:** 
- **Value:** -16.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.3
- **Upper Limit:** 
- **Value:** -5.7
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -2.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.4
- **Upper Limit:** 
- **Value:** 7.4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.0
- **Upper Limit:** 
- **Value:** 7.7
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -0.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.3
- **Upper Limit:** 
- **Value:** 6.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** 8.6
**Title:** 
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.8
- **Upper Limit:** 
- **Value:** 1.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.7
- **Upper Limit:** 
- **Value:** -10.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.9
- **Upper Limit:** 
- **Value:** -9.2
**Title:** 
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.9
- **Upper Limit:** 
- **Value:** 2.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.7
- **Upper Limit:** 
- **Value:** -11.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.8
- **Upper Limit:** 
- **Value:** -3.0
**Title:** 
#### Outcome Measure 25
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.5
- **Upper Limit:** 
- **Value:** 3.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.1
- **Upper Limit:** 
- **Value:** 8.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.5
- **Upper Limit:** 
- **Value:** 10.0
**Title:** 
#### Outcome Measure 26
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.5
- **Upper Limit:** 
- **Value:** 2.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.1
- **Upper Limit:** 
- **Value:** 5.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.5
- **Upper Limit:** 
- **Value:** 7.6
**Title:** 
#### Outcome Measure 27
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18.8
- **Upper Limit:** 
- **Value:** -37.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 21.2
- **Upper Limit:** 
- **Value:** -41.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 13.3
- **Upper Limit:** 
- **Value:** -46.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 48
- **Group ID:** OG001
- **Value:** 98
- **Group ID:** OG002
- **Value:** 45
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 22.0
- **Upper Limit:** 
- **Value:** -36.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 21.2
- **Upper Limit:** 
- **Value:** -39.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 13.7
- **Upper Limit:** 
- **Value:** -43.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 48
- **Group ID:** OG001
- **Value:** 96
- **Group ID:** OG002
- **Value:** 46
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 24.2
- **Upper Limit:** 
- **Value:** -46.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18.7
- **Upper Limit:** 
- **Value:** -49.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 21.7
- **Upper Limit:** 
- **Value:** -48.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 47
- **Group ID:** OG001
- **Value:** 91
- **Group ID:** OG002
- **Value:** 44
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 20.6
- **Upper Limit:** 
- **Value:** -50.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 19.5
- **Upper Limit:** 
- **Value:** -53.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 21.3
- **Upper Limit:** 
- **Value:** -52.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 50
- **Group ID:** OG001
- **Value:** 94
- **Group ID:** OG002
- **Value:** 47
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 20.4
- **Upper Limit:** 
- **Value:** -49.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 19.6
- **Upper Limit:** 
- **Value:** -52.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 22.0
- **Upper Limit:** 
- **Value:** -46.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 48
- **Group ID:** OG001
- **Value:** 90
- **Group ID:** OG002
- **Value:** 44
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 20.9
- **Upper Limit:** 
- **Value:** -50.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18.7
- **Upper Limit:** 
- **Value:** -53.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 24.1
- **Upper Limit:** 
- **Value:** -51.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 46
- **Group ID:** OG001
- **Value:** 81
- **Group ID:** OG002
- **Value:** 37
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17.6
- **Upper Limit:** 
- **Value:** -52.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.7
- **Upper Limit:** 
- **Value:** -48.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 20.9
- **Upper Limit:** 
- **Value:** -49.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 38
- **Group ID:** OG001
- **Value:** 72
- **Group ID:** OG002
- **Value:** 29
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 24.2
- **Upper Limit:** 
- **Value:** -47.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 17.1
- **Upper Limit:** 
- **Value:** -66.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 4.6
- **Upper Limit:** 
- **Value:** -60.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 13
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)
**Type:** PRIMARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 2
**Description:** Adjusted LS means and standard errors at Week 24 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) (on-treatment analysis).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 3
**Description:** Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 4
**Description:** Adjusted LS means and standard errors at Week 12 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).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 5
**Description:** Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 - ITT- Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 6
**Description:** Adjusted LS means and standard errors at Week 12 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) and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 7
**Description:** Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 8
**Description:** Adjusted LS means and standard errors at Week 24 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).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT population. Number of participants analyzed = participants of the mITT population with available data at specified time-points.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 9
**Description:** Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 10
**Description:** Adjusted LS means and standard errors at Week 24 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).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 11
**Description:** Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Total-C at Week 24 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 12
**Description:** Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 13
**Description:** Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 14
**Description:** Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 15
**Description:** Moderate CV risk: 10-year fatal cardiovascular disease (CVD) risk Systemic Coronary Risk Evaluation (SCORE) ≥1 and \<5%.

High CV risk: 10-year fatal CVD risk SCORE ≥5% or moderate chronic kidney disease or type 1 or type 2 diabetes mellitus without target organ damage or familial hypercholesterolemia.

Very high CV risk: history of documented coronary heart disease, ischemic stroke, peripheral artery disease, transient ischemic attack, abdominal aortic aneurysm, or carotid artery occlusion \>50% without symptoms; carotid endarterectomy or carotid artery stent procedure; renal artery stenosis, or renal artery stent procedure; or type 1 or type 2 diabetes mellitus with target organ damage.

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.
**Parameter Type:** NUMBER
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 16
**Description:** Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
**Parameter Type:** NUMBER
**Population Description:** mITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 - On-treatment Analysis
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 17
**Description:** Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
**Parameter Type:** NUMBER
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percentage of Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) at Week 24 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 18
**Description:** Adjusted percentages at Week 24 from LOCF approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
**Parameter Type:** NUMBER
**Population Description:** mITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 - On-treatment Analysis
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 19
**Description:** Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 20
**Description:** Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 21
**Description:** Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 22
**Description:** Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 23
**Description:** Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 24
**Description:** Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** ITT population.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 25
**Description:** Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 26
**Description:** Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
**ID:** OG000
**Title:** Placebo Q2W
##### Group
**Description:** Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Outcome Measure 27
**Description:** Mean percent changes (and standard deviations) observed during the open-label extension period are provided.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Open-label extension population included all participants who received at least one dose or part of dose of Alirocumab during the open label extension period. Here, "number analyzed" signifies the number of participants evaluable for each specified time-point.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 32, 36, 48, 72, 96, 120, 144 and Week 168
**Title:** Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** percent change
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first, in participants who received placebo (for Alirocumab) Q2W for 24 weeks during the double-blind period. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
**ID:** OG000
**Title:** Alirocumab 150 mg Q4W (After Placebo Q2W)
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first, in participants who received Alirocumab 75 mg Q2W/Up to 150 mg Q2W for 24 weeks during the double-blind period. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
**ID:** OG001
**Title:** Alirocumab 150 mg QW4 (After Alirocumab 75 Q2W/Up 150 Q2W)
##### Group
**Description:** Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first, in participants who received 150 mg Q4W/Up to 150 mg Q2W for 24 weeks during the double-blind period. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
**ID:** OG002
**Title:** Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up 150 Q2W)
### Participant Flow Module
#### Group
**Description:** Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.

Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
**ID:** FG000
**Title:** Placebo Q2W
#### Group
**Description:** Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.

Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
**ID:** FG001
**Title:** Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
#### Group
**Description:** Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or \<30% LDL-C reduction from baseline.

Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
**ID:** FG002
**Title:** Alirocumab 150 mg Q4W/Up to 150 mg Q2W
#### Period
**Title:** Period 1: 24-Week Double-blind Treatment
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 5
##### Withdraw
**Type:** Poor compliance to protocol
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Consent withdrawn by participant
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Randomized but not treated
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Other than specified above
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 58
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 116
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 59
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 58
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 115
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 58
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 54
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 107
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 50
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 9
#### Period
**Title:** Extension Open Label Treatment
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Poor compliance to protocol
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Participant moved
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Other than specified above
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 51
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 106
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 48
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 46
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 89
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 43
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 17
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 5
**Pre-Assignment Details:** Randomization was stratified by statin intolerant status \& background therapy (non-statin lipid therapy vs diet). Randomization followed a 1:2:1 ratio for placebo, Alirocumab 75 mg and Alirocumab 150 mg instead of 1:1:2 as initially planned due to systematic error in treatment allocation algorithm discovered after all participants were randomized.
**Recruitment Details:** The study was conducted at 43 centers in 8 countries. A total of 402 participants were screened between December-2013 and May-2014, of whom 233 were randomized for double-blind (DB) treatment period and 169 were screen failures. Out of 233 randomized for DB period, 205 participants entered the optional open-label (OL) extension period.
**Has Results:** True