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

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.

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.