Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

The maximum study duration was 115 weeks per participant, including a 3-week screening
period, 104-week randomized treatment period and 8-week follow-up period.

Inclusion criteria:

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD
risk equivalents who were not adequately controlled with a maximally tolerated daily dose
of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria:

- Age < 18 or legal age of adulthood, whichever was greater

- Participants without established CHD or CHD risk equivalents

- LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented
cardiovascular disease

- LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented CV
disease

- Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L)

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