Braaskamp 2015a

Methods	* Design: RCT * Randomization stratified by age and baseline LDL‐C * Blinding: double * Concealment of allocation: nr * Setting: 10 centers * Country: Netherlands, Greece, Norway, Italy, Spain, France * Follow‐up: 12 weeks
Participants	Individuals with HeFH (N = 103) * Diagnosis: documented genetic effect or LDL‐C ≧ 160 mg/dL or LDL‐C > 130 mg/dL and male, early CVD in family, HDL‐C < 45 mg/dL, TG > 150 mg/dL, lipoprotein(a) > 75 nmol/L, type 2 diabetes mellitus diagnosed and blood pressure > 95th percentile for age and height. * Inclusion: age 6 ‐ 17 years, HeFH * Exclusion: nr * Base population: nr Age: 6 ‐ 17 years Male: 45% Height (mean): 148 cm Weight (mean): 44 kg BMI (mean): 19.1 kg/m² LDL‐C (mean): 232 mg/dL
Interventions	* Treatment: pitavastatin in 3 treatment arms (n = 76), 1 mg daily (n = 26), 2 mg daily (n = 26) and 4 mg daily (n = 24) * Control: placebo (n = 27) * Run‐in: diet only for 5 weeks * Diet: nr
Outcomes	LDL‐C (SD for mean percentage change not reported) TC (SD for mean percentage change not reported) HDL‐C (SD for mean percentage change not reported) TG (SD for mean percentage change not reported) ASAT ALAT CK Myopathy: myalgia Adverse events: (adverse event not reported separately for the treatment groups)
Notes	No indication to suspect selective reporting.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	nr; multicenter study, central randomization assumed.
Allocation concealment (selection bias)	Unclear risk	nr
Blinding (performance bias and detection bias) All outcomes	Low risk	Double blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	Compliance: nr Dropout: 3% Losses to follow‐up: 0% Missing from analysis: 0%
Selective reporting (reporting bias)	Unclear risk	No indication to suspect selective reporting.