Motomura 2009.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 4‐week washout period; 3‐month before‐and‐after study
Participants	Baseline Characteristics 2 mg n: 65 Age (years): 62 Males (n): 30 Females (n): 35 BMI: 24.4 Total cholesterol: 250 mg/dL (6.465 mmol/L) LDL cholesterol: 165 mg/dL (4.27 mmol/L) HDL cholesterol: 59 mg/dL (1.53 mmol/L) Included criteria: more than 20 years old, no chronic or acute inflammatory diseases diagnosed by clinical symptoms and/or laboratory data, no corticosteroid administration, serum creatinine concentrations ＜ 2.0 mg/dL, serum transaminase concentrations less than twice the upper limit of control ranges, and no viral hepatitis Excluded criteria: none reported Baseline Group Characteristics: NR
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
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	High risk	Judgement Comment: This work was supported in part by a grant from the Ministry of Education, Science and Sports of Japan and "an unrestricted grant" from Kowa Pharmaceutical.
Incomplete outcome data (attrition bias) Total cholesterol	High risk	[(91 ‐ 65)/91]*100 = 28.6% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	High risk	[(91 ‐ 65)/91]*100 = 28.6% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	High risk	[(91 ‐ 65)/91]*100 = 28.6% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	High risk	[(91 ‐ 65)/91]*100 = 28.6% 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