Table 1 Detailed inclusion and exclusion criteria for METEOR-China

Inclusion criteria

 • Provision of informed consent prior to any study-specific procedures

 • Male aged ≥ 45 and < 70 years or female aged ≥ 55 and < 70 years

 • Subjects with only hypertension (defined as blood pressure ≥ 140/90 mmHg or on antihypertensive treatment) and age (male ≥ 45 years, females ≥ 45 years) as CVD risk factors and subjects without hypertension who have three or more other risk factors (including age) must have the following:

  - Fasting LDL-C of ≥ 120 mg/dL (3.1 mmol/L) and < 160 mg/dL (4.1 mmol/L)

 • Subjects without hypertension who have fewer than three other risk factors (including age) must have the following:

  - Fasting LDL-C of ≥ 120 mg/dL (3.1 mmol/L) and < 190 mg/dL (4.9 mmol/L)

 • Triglycerides < 500 mg/dL (5.65 mmol/L) at visit 1 (week − 6)

 • HDL-C levels ≤ 60 mg/dL (1.6 mmol/L) at visit 1 (week − 6)

 • Maximum IMT ≥ 1.2 mm and < 3.5 mm at any location in the carotid ultrasound scans conducted at both visit 2 (week − 4) and visit 3 (week − 2)

 • Willing to follow all study procedures including study visits, fasting blood draws, and compliance with the study treatment regimen

Exclusion criteria

 • Use of pharmacologic lipid-lowering medications (e.g. statins, fibrate derivatives, bile acid-binding resins, niacin, or its analogues at doses > 400 mg or prescribed Chinese traditional drugs), including CAIs and CAI/statin combination, within 12 months prior to visit 1 (week − 6)

 • Current or recent (within 2 weeks of visit 1, week − 6) use of supplements known to alter lipid metabolism (e.g. soluble fibres [including > 2 teaspoons Metamucil® or psyllium-containing supplement per day] or other dietary fibre supplements, marine oils, sterol/stanol products, or other supplement determined at the discretion of the investigator)

 • History of hypersensitivity reactions to other HMG-CoA reductase inhibitors

 • Pregnant women, women who are breastfeeding, and women of childbearing potential who are not using chemical or mechanical contraception or who have a positive serum pregnancy test

 • Clinical evidence of CAD or any other atherosclerotic disease such as angina, MI, transient ischaemic attack, symptomatic CAD, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, peripheral arterial disease, and abdominal aortic aneurysm

 • History of cancer (other than basal cell carcinoma) in the past 2 years

 • Uncontrolled hypertension defined as either a mean resting diastolic blood pressure of ≥ 110 mmHg or a resting systolic blood pressure of ≥ 180 mmHg recorded at any time during the screening period

 • History of diabetes mellitus or current diabetes mellitus

 • Uncontrolled hypothyroidism defined as a thyroid-stimulating hormone > 1.5 times the ULN at visit 1 or subjects whose thyroid replacement therapy was initiated within the last 3 months

 • History of heterozygous or homozygous familial hypercholesterolaemia or known hyperlipoproteinaemia types I, III, IV, or V (familial dysbetalipoproteinaemia)

 • Use of the disallowed concomitant medications within 12 months prior to visit 1 (week − 6)

 • History of alcohol and/or drug abuse within the past 5 years

 • Active liver disease or hepatic dysfunction as defined by elevations of ≥ 1.5× ULN at visit 1 (week − 6) in any of the following liver function tests: ALT, AST, or bilirubin

 • Serum CK > 3× ULN at visit 1 (week − 6)

 • Serum creatinine > 2.0 mg/dL (177 mmol/L) recorded during the screening period

 • Participation in another investigational drug study and having ingested investigational drug ≤ 4 weeks before enrolment in the screening period

 • Previous randomisation in the present study

 • History of a significant medical or psychological condition that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study

 • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)