Nakaya 1995.

Methods	Study design: prospective, randomised trial Setting/location: Tokai University Tokyo Hospital. Country: Japan Period of study: August‐December 1990 Unit of randomisation: participant Unit of analysis: participant Trial test: not reported Analysis strategy: intention‐to‐treat
Participants	Inclusion criteria: Cholesterol total concentration greater than 220 mg/dL Male Age 20‐65 years No comorbidity Exclusion criteria: Hypothyroidism Cushing and nephrotic syndromes Biliary‐tract disease Pancreatitis Lupus erythematosus Lymphoma, myeloma and pheochromocytoma Uncontrolled diabetes and hypertension Secondary hyperlipidaemia Low‐fat diet Cognitive disability, renal disease Drug hypersensitivity Randomised: 22 Participants assessed (ITT analysis): 22 Definition of hyperlipidemia: not described Baseline characteristics: Total cholesterol (TC) (mg/dL) (mean (SD)): M‐DG: 243.6 (9.4), E‐DG: 248.7 (10) & ME‐G: 239.3 (7.5) LDL‐C (mg/dL) (mean (SD)): M‐DG: 156.9 (8.3), E‐DG: 160.6 (12.5) & ME‐G: 156.9 (7.6) HDL‐C (mg/dL) (mean (SD)): M‐DG: 50.8 (2.9), E‐DG: 51.2 (3.8) & ME‐G: 50.4 (2.1) Triglycerides (mg/dL) (mean (SD)): M‐DG: 190.7 (43.4), E‐DG: 192.8 (37.6) & ME‐G: 160 (12.5)
Interventions	Type of interventions: morning vs evening doses of fluvastatin M‐DG: fluvastatin 10 mg E‐DG: fluvastatin 10 mg Morning‐Evening group (ME‐G): fluvastatin 5 mg (twice a day) Duration of intervention: Washout period: 2 weeks (placebo) Treatment phase: 4 weeks Follow‐up observation period: 2 weeks (placebo)
Outcomes	Lipid levels: TC, LDL‐C, HDL‐C and triglycerides (mg/dL)
Notes	Translated (original in Japanese)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The study described a permuted‐block randomisation
Allocation concealment (selection bias)	Low risk	Central allocation controlled by the Pharmacy Service
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The authors were concerned to blind the treatment, all tablets were similar and indistinguishable
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of outcome assessors not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not available the flow chart of the study
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement of ‘low risk’ or ‘high risk’
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias existed