Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Brief Summary: This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).


Options:
A: Inclusion criteria:

* Participants diagnosed with Type 1 or Type 2 diabetes at least one year prior to the screening visit (Week -3).
* Signed written informed consent
* Participants with type 1 or type 2 diabetes treated with insulin whose LDL-C levels were not adequately controlled with maximally tolerated lipid-modifying therapy
* LDL-C of 70 mg/dL or greater
* 18 years of age or more
* Glycosylated hemoglobin (HbA1c) less than 10%
* History of cardiovascular disease (including coronary heart disease \[CHD\] and/or CHD risk equivalents) and/or at least one additional cardiovascular risk factor

Exclusion criteria:

* Not on a stable dose of statin or other lipid modifying therapy for at least 4 weeks prior to screening or from screening to randomization, unless statin intolerant
* Triglycerides \>400 mg/dL
* Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m² according to the Modification of Diet in Renal Disease (MDRD) equation
* Currently received or planned to receive renal replacement therapy (for example, hemodialysis)
* Change in weight of more than 5 kilograms within the prior 2 months
* Not on a stable dose/regimen of insulin or other antidiabetic drugs for the past 3 months or planned to intensify insulin regimen during the study
* Not treated with insulin for at least 6 months
* Planned to start new lipid modifying therapy or change dose of current lipid modifying therapy during the study
* Body mass index (BMI) \>45 kg/m² or planned to undergo bariatric surgery, weight loss program, or initiate weight loss drugs during the study
* History of recent decompensation of diabetes within the prior 2 months (for example, diabetic ketoacidosis)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
B: 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.
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.
* Heterozygous familial hypercholesterolemia.

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:

1. Patients with heFH\* who are not adequately controlled\*\* with a maximally-tolerated daily dose\*\*\* of statin with or without other LMT, at a stable dose prior to the screening visit (week -2).

   \*Diagnosis of heFH must be made either by genotyping or by clinical criteria. For those patients not genotyped, the clinical diagnosis may be based on either the Simon Broome criteria for definite FH (Appendix 1) or the WHO/Dutch Lipid Network criteria with a score of \>8 points (Appendix 2).

   \*\* "Not adequately controlled" is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) at the screening visit (week -2) in patients with a history of documented CVD (Appendix 3), or LDL-C ≥100 mg/dL (2.59 mmol/L) at the screening visit (week -2) in patients without a history of documented CVD.

   \*\*\* "Maximally-tolerated dose" is defined as (any of the following are acceptable):
   * Rosuvastatin 20 mg or 40 mg daily
   * Atorvastatin 40 mg or 80 mg daily
   * Simvastatin 80 mg daily (if already on this dose for \>1 year - see exclusion criterion #7)

   Note: Patients who are not able to be on any of the above statin doses should be treated with the dose of daily atorvastatin, rosuvastatin, or simvastatin which is considered appropriate for the patient, according to the investigator's judgment. Some examples of acceptable reasons for a patient taking a lower statin dose include, but are not limited to: adverse effects on higher doses, advanced age, low body mass index, regional practices, local prescribing information, concomitant medications, co-morbid conditions such as impaired glucose tolerance/impaired fasting glucose. The reason(s) will be documented in the case report form (CRF).
2. Provide signed informed consent

Exclusion Criteria:

1. Patient without diagnosis of heFH made either by genotyping or by clinical criteria
2. LDL-C \<70 mg/dL (\<1.81 mmol/L) at the screening visit (week-2) in patients with history of documented cardiovascular disease
3. LDL-C \<100 mg/dL (\<2.59 mmol/L) at the screening visit (week -2) in patients without history of documented cardiovascular disease
4. Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (week -2) and from screening to randomization
5. Currently taking another statin than simvastatin, atorvastatin, or rosuvastatin
6. Simvastatin, atorvastatin, or rosuvastatin is not taken daily or not taken at a registered dose
7. Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg (except for patients on simvastatin 80 mg for more than 1 year, who are eligible)
8. Use of fibrates, other than fenofibrate within 6 weeks of the screening visit (week-2) or between screening and randomization visits
9. Use of nutraceutical products or over-the-counter therapies that may affect lipids which have not been at a stable dose/amount for at least 4 weeks prior to the screening visit (week -2) or between screening and randomization visits
10. Use of red yeast rice products within 4 weeks of the screening visit (week-2), or between screening and randomization visits
11. Patient who has received plasmapheresis treatment within 2 months prior to the screening visit (week -2), or has plans to receive it during the study
12. Recent (within 3 months prior to the screening visit \[week -2\] or between screening and randomization visits) MI, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack (TIA), carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease

(The inclusion/exclusion criteria provided above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial).

Answer: D