Simons 2002.

Methods	4‐week dietary/washout period 4‐week RCT
Participants	152 men and women with primary hypercholesterolaemia aged ≥ 18 years LDL‐C ≥ 97 mg/dL (2.5 mmol/L), TG ≤ 400 mg/dL (4.5 mmol/L) Exclusion criteria: none reported Placebo baseline TC: 7.66 mmol/L (296.2 mg/dL) Placebo baseline LDL‐C: 5.42 mmol/L (209.6 mg/dL) Placebo baseline HDL‐C: 1.36 mmol/L (52.6 mg/dL) Placebo baseline TG: 1.97 mmol/L (174.5 mg/dL) Cerivastatin 0.4 mg/d baseline TC: 7.50 mmol/L (290 mg/dL) Cerivastatin 0.4 mg/d baseline LDL‐C: 5.22 mmol/L (201.9 mg/dL) Cerivastatin 0.4 mg/d baseline HDL‐C: 1.39 mmol/L (53.7 mg/dL) Cerivastatin 0.4 mg/d baseline TG: 1.97 mmol/L (174.5 mg/dL)
Interventions	Placebo + regular margarine evening dosing Placebo + sterol‐ester margarine evening dosing Cerivastatin 0.4 mg/d + regular margarine evening dosing Cerivastatin 0.4 mg/d + sterol‐ester margarine evening dosing
Outcomes	Percentage change from baseline at 4 weeks of plasma TC, LDL‐C, HDL‐C, TG and WDAEs
Source of funding	Bayer
Notes	SDs were imputed by the method of Furukawa 2006
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of random sequence generation was not reported
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind Cerivastatin and placebo tablets were all identical in appearance
Blinding of outcome assessment (detection bias) LDL‐C	Low risk	Lipid parameters were measured in a remote laboratory
Blinding of outcome assessment (detection bias) WDAE	High risk	WDAEs were not reported
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias) LDL cholesterol	Low risk	All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias) Triglycerides	Low risk	All participants were included in the efficacy analysis
Selective reporting (reporting bias)	Low risk	LDL‐C was reported
Other bias	Unclear risk	Bayer and Unilever funded the trial