Noji 2002.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 4‐8 week placebo washout period; 8‐week before‐and‐after study with evening dosing
Participants	Baseline Characteristics 2 mg n: 25 Age (years): 53 Males (n): 11 Females (n): 14 Total cholesterol: 340 mg/dL (8.79 mmol/L) LDL cholesterol: 267 mg/dL (6.90 mmol/L) HDL cholesterol: 48 mg/dL (1.24 mmol/L) BMI: 24.6 Included criteria: 25 patients with heterozygous familial hypercholesterolaemia with primary hypercholesterolaemia (TC > 230 mg/dL) with tendon xanthoma or first‐degree relatives of previously diagnosed heterozygous FH patients. Achilles’ tendon xanthoma was observed in 21 patients and xanthelasma in four. Excluded criteria: not reported. Baseline Group Characteristics:NR
Interventions	Intervention Characteristics 2 mg
Outcomes	Total cholesterol Outcome type: Continuous Unit of measure:Ppercentage 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	Stephen P on 02/02/2018 08:37 Outcomes Given versus calculated percentage changes from baseline for triglycerides had a greater than 10% difference (‐14.0 vs 0.0), therefore, the triglyceride outcome was not reported.
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	High risk	[(36 ‐ 25)/36]*100 = 30.6% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	High risk	[(36 ‐ 25)/36]*100 = 30.6% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	High risk	[(36 ‐ 25)/36]*100 = 30.6% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	High risk	[(36 ‐ 25)/36]*100 = 30.6% 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