Dallongeville 1994a.

Methods	lipid‐lowering treatment was discontinued for 10 weeks (1 year for probucol) prior to the study start 6‐week dietary placebo run‐in period 6‐week randomised placebo‐controlled double‐blind trial
Participants	429 men and women LDL‐C > 160 mg/dL (4.14 mmol/L) and premature CHD and/or two associated risk factors LDL‐C > 190 mg/dL (4.91 mmol/L) and no CHD, plus triglycerides < 300 mg/dL (3.39 mmol/L) Placebo baseline LDL‐C : 6.53 mmol/dL (253 mg/dL) Fluvastatin 2.5 mg/day baseline LDL‐C : 6.74 mmol/L (261 mg/dL) Fluvastatin 5 mg/day baseline LDL‐C : 6.76 mmol/L (261 mg/dL) Fluvastatin 10 mg/day baseline LDL‐C : 6.24 mmol/L (241 mg/dL) Fluvastatin 20 mg/day baseline LDL‐C : 6.24 mmol/L (241 mg/dL)
Interventions	Placebo for 6 weeks Fluvastatin 2.5 mg/day for 6 weeks Fluvastatin 5 mg/day for 6 weeks Fluvastatin 10 mg/day for 6 weeks Fluvastatin 20 mg/day for 6 weeks
Outcomes	per cent change from baseline at 6 weeks of LDL‐C
Source of Funding	unknown
Notes	TC, HDL‐C, triglycerides and WDAEs were not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Random sequence generation method not reported
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind Lipid parameter measurements unlikely influenced by lack of proper blinding
Blinding of outcome assessment (detection bias) LDL‐cholesterol	Low risk	LDL‐C was determined by the Pasteur Institute Central Laboratory
Blinding of outcome assessment (detection bias) WDAEs	High risk	WDAEs were not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	0.2% participants were not included in the efficacy analysis
Selective reporting (reporting bias)	Low risk	LDL‐C outcome was reported
Other bias	Unclear risk	Source of funding was not reported