Long Term Safety Study of PRALUENT
Long Term Safety Study of PRALUENT
The primary objective of the study is to evaluate the long term safety of PRALUENT in
 participants with heterozygous familial hypercholesterolemia (heFH) or non-familial
 hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed
 the neurocognitive function study (R727-CL-1532: NCT02957682).

 The secondary objectives of the study are:

 -  To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)

 -  To evaluate the effect of PRALUENT on other lipid parameters

 -  To evaluate the effect of PRALUENT on gonadal steroid hormones
Key Inclusion Criteria:

 Participants randomized into the neurocognitive function study (R727-CL-1532) who completed
 treatment and the end of study (EOS) visit with no premature or permanent discontinuation
 of study drug.

 Key Exclusion Criteria:

 1. Significant protocol deviation in the parent study (neurocognitive function study,
 R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as
 noncompliance

 2. Any participant who experienced an AE leading to permanent discontinuation from the
 neurocognitive function study, (R727-CL-1532: NCT02957682).

 3. Any new condition or worsening of an existing condition which, in the opinion of the
 investigator or per the PRALUENT local label, would make the participant unsuitable
 for enrollment or could interfere with the participant participating in or completing
 the open-label extension (OLE) study

 4. Known hypersensitivity to monoclonal antibody or any component of the drug product

 5. Pregnant or breastfeeding women

 Note: Other inclusion/ exclusion criteria apply