Please select the eligibility criteria that correspond to the clinical trial below.
Title: Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study
Brief Summary: Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

* To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
* To evaluate the effects of alirocumab on other lipid parameters.


Options:
A: Inclusion criteria:

Either A or B below and who were not adequately controlled with their lipid-modifying therapy:

A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents

OR

B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents.

Exclusion criteria:

* Age \< 18 years
* LDL-C \<70 mg/dL (\< 1.81 mmol/L)
* Fasting serum triglycerides \> 400 mg/dL (\>4.52 mmol/L)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
B: Inclusion Criteria:

* Clinically stable participants may be eligible to enroll within 10 days following hospital admission with high-risk acute coronary syndrome (either ST-elevation myocardial infarction \[STEMI\] or Non-STEMI or unstable angina)
* Participants not taking a statin must have an LDL-C of 125 mg/dl or less. Participants taking a statin must have an LDL-C of 100 mg/dl or less.

Exclusion Criteria:

* Pregnant or lactating woman, or intending to become pregnant
* Participant with active liver disease or persistent unexplained serum transaminase elevation
* History of alcohol or drug abuse
* History of sensitivity to statin or ezetimibe
* A participant for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.
C: Inclusion Criteria:

* Treated with a statin.
* Fasting LDL-C \> 70 mg/dL and triglyceride \<=400 mg/dL.
* High or very high risk of incurring a cardiovascular event.

Exclusion Criteria:

* Pregnant or breastfeeding females.
* Cardiovascular or cerebrovascular event of procedures during the past 30 days.
* Congestive heart failure NYHA class IV.
* Poorly controlled hypertension.
D: Inclusion Criteria:

* Male or female 18 to 65 years of age.
* Weight\> 50 kg and \<95 kg inclusive
* For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day 1.
* For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant during the full duration of the study.
* Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
* Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria:

* Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
* Pregnant or breast-feeding women.
* Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
* Hospitalization for any reason within 60 days of screening.
* Known history of Human Immunodeficiency Virus (HIV) antibody; and/or positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit.
* Previous exposure to any therapeutic or investigational biological agent.
* History of alcohol or substance abuse within previous 5 years.

Answer: A