Nozue 2008.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 8‐week washout period; 12‐week before‐and‐after study
Participants	Baseline Characteristics 2 mg n: 8 Age (years): 62 Males (n): 1 Females (n): 7 BMI: 22.9 Total cholesterol: 286 mg/dL (7.40 mmol/L) LDL cholesterol: 201 mg/dL (5.20 mmol/L) HDL cholesterol: 58 mg/dL (1.50 mmol/L) Triglycerides: 165 mg/dL (1.86 mmol/L) Included criteria: Eight patients with heterozygous familial hypercholesterolaemia (male/female = 1/7, mean age = 62 ± 6 years) were studied. FH was diagnosed according to the following two criteria: primary hypercholesterolaemic patients (TC level above 230 mg/dL in any age group) with tendon xanthomas, or primary hypercholesterolaemic patients with and without tendon xanthomas in a first‐degree relative of familial hypercholesterolaemic patients. Excluded criteria: Not reported Baseline Group Characteristics: There was no significant difference in age, gender, body mass index, TC, LDL‐C, HDL‐C, TG, sd‐LDL‐C and RLP‐C levels between the two groups
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	Unclear risk	Judgement Comment: Source of funding was 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.
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported