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

Inclusion Criteria:

1. Patients with LDL-C greater than or equal to 70 mg/dL at the screening visit and who
are not adequately controlled with a stable daily dose of rosuvastatin, with or
without other LMT.

OR

2. Patients with screening LDL-C greater than or equal to 100 mg/dL who are not
adequately controlled with a stable daily dose of rosuvastatin before the screening
visit, with or without other LMT.

Exclusion Criteria:

1. LDL-C less than 70 mg/dL at the screening visit in patients with history of
documented cardiovascular disease (CVD)

2. LDL-C less than 100 mg/dL at the screening visit in patients without history of
documented coronary heart disease (CHD) or non-CHD CVD, but with other risk factors

3. Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping)

4. Recent (within 3 months prior to the screening visit) myocardial infarction (MI),
unstable angina leading to hospitalization, percutaneous coronary intervention (PCI),
coronary bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke,
transient ischemic attack, carotid revascularization, endovascular procedure or
surgical intervention for peripheral vascular disease

5. Newly diagnosed (within 3 months prior to randomization visit) or poorly controlled
diabetes

6. Presence of any clinically significant uncontrolled endocrine disease known to
influence serum lipids or lipoproteins

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