Liu 2013.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 4‐week dietary lead‐in period; 12‐week before‐and‐after study
Participants	Baseline Characteristics 2 mg n: 112 Age (years): 58.7 Males (n): 69 Females (n): 43 BMI: 26.6 Total cholesterol: 213 mg/dL (5.51 mmol/L) LDL cholesterol: 149.6 mg/dL (3.87 mmol/L) HDL cholesterol: 48.7 mg/dL (1.26 mmol/L) Triglycerides: 156 mg/dL (1.76 mmol/L) Included criteria: Eligible patients were men and women aged 20 or older with fasting LDL‐C higher than 100 mg/dL. In addition, to be considered “high‐risk”, a patient had to meet at least one of the following criteria (NCEP ATP III guideline): documented CHD; type 2 DM; the patient had fewer than 2 risk factors (other than LDL) present in the following items without CHD or a CHD risk equivalent, a 10‐year (short‐term) CHD risk had to be assessed with a Framingham score > 20%: female: ≥ 55 years old, or male: ≥ 45 years old; fasting high‐density lipoprotein cholesterol (HDL‐C) 40 mg/dL; a family history of premature CHD (CHD in first‐degree male relative 55 years; CHD in first‐degree female relative 65 years); hypertension (BP ≥ 140/90 mm Hg or treated with anti‐hypertensive agents); HDL‐C ≥ 60 mg/dL counted as a“negative” risk factor; its presence removed one risk factor from the total count. Excluded criteria: a history of hypersensitivity to statins, hepatic dysfunction [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 100 IU/L], suspected hepatic metabolism disorders or biliary obstruction (acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice), or renal dysfunction (serum creatinine > 1.5 mg/dL), pregnancy, possible pregnancy, or breastfeeding and poorly controlled diabetes (HbA1C > 9.0%) Baseline Group Characteristics: The characteristics of the 2 groups were similar at baseline.
Interventions	Intervention Characteristics 2 mg
Outcomes	Total cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better LDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better HDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Higher is better Triglycerides Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Judgement Comment: Controlled before‐and‐after design
Allocation concealment (selection bias)	High risk	Judgement Comment: Controlled before‐and‐after design
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Judgement Comment: Lipid parameter measurements unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Judgement Comment: Lipid parameters were measured in a remote laboratory.
Selective reporting (reporting bias)	Low risk	Judgement Comment: LDL‐cholesterol outcome was reported.
Other bias	Low risk	Judgement Comment: The associated study (Lin 2014) was partly supported by research grants V101B‐023, V102B‐048 and V103B‐019 toL.Y. Lin. from the Taipei Veterans General Hospital, Taipei, Taiwan. Kowa company supplied the medicine for the clinical trial.
Incomplete outcome data (attrition bias) Total cholesterol	High risk	[(113 ‐ 94)/113]*100 = 16.8% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	High risk	[(113 ‐ 94)/113]*100 = 16.8% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	High risk	[(113 ‐ 94)/113]*100 = 16.8% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	High risk	[(113 ‐ 94)/113]*100 = 16.8% were not included in the efficacy analysis.
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported