Table 1.

Key Inclusion and Exclusion Criteria

Inclusion Criteria
Patients with hypercholesterolemia (non‐FH or heFH) at high CV risk with LDL‐C levels above those prespecified and receiving:
OPTIONS I	OPTIONS II
Atorvastatin (20 mg or 40 mg daily), with or without other LLT (excluding ezetimibe), for ≥4 weeks prior to screening visit	Rosuvastatin (10 mg or 20 mg daily), with or without other LLT (excluding ezetimibe), for ≥4 weeks prior to screening visit
Baseline Entry Criteria
Inclusion criteria
Patients with LDL‐C levels ≥70 mg/dL (≥1.81 mmol/L) at the screening visit with a history of documented CVD; patients with a history of documented CHD, non‐CHD CVD, or DM with target organ damage
Patients with LDL‐C levels ≥100 mg/dL (≥2.59 mmol/L) at the screening visit in patients without history of documented CVD; patients must also have heFH, or have non‐FH, without CHD or non‐CHD CVD, but with calculated 10‐year fatal CVD risk SCORE ≥5%, or with moderate CKD, or with DM but no target organ damage
Exclusion criteria
Age <18 years
Fasting serum TG >400 mg/dL (>4.52 mmol/L) during the screening period
Currently taking ezetimibe, or had received ezetimibe, within 4 weeks of the screening visit
Uncontrolled endocrine disease known to influence serum lipids
OPTIONS I	OPTIONS II
Currently taking a statin that is not atorvastatin daily at 20 mg or 40 mg	Currently taking a statin that is not rosuvastatin daily at 10 mg or 20 mg

Abbreviations: CHD, coronary heart disease; CKD, chronic kidney disease; CV, cardiovascular; CVD, cardiovascular disease; DM, diabetes mellitus; heFH, heterozygous familial hypercholesterolemia; LDL‐C, low‐density lipoprotein cholesterol; LLT, lipid‐lowering therapy; non‐FH, non‐familial hypercholesterolemia; SCORE, systematic coronary risk evaluation; TG, triglycerides.