Clauss 2005

Methods	* Design: RCT * Randomization process: nr * Blinding: double * Concealment of allocation: by randomised numbers * Setting: 12 medical centers * Country: USA * Follow‐up: 4 and 24 weeks
Participants	* Participants with HeFH (N = 54) * Diagnosis: 1 parent with FH, LDL‐C > 4.1mmol/L * Inclusion: age 10 ‐ 17 years; female; LDL‐C 4.1‐10.3 mmol/L on diet; TG < 4.0 mmol/L; postmenarchal > 1 year * Exclusion: pregnancy; under/overweight; HoFH; dyslipidemia I, III‐V; DM, hypothyroidism; renal disorder; certain medication (immunosuppressants, corticosteroids, cytochrome P‐450 inhibitors) * Base population: unclear; 81 individuals were screened * Age: 11 ‐ 18 years * Male: 0% * Race: nr * Height (mean): 164 cm * Weight (mean): 60 kg * BMI (mean): 23 kg/m² * LDL‐C (mean): 5.5 mmol/L
Interventions	* Intervention: lovastatin 40 mg daily; started with 20 mg for 4 weeks, then increased to 40 mg (n = 35) * Control: placebo (n = 19) * Drugs discontinued 6 ‐ 8 weeks before randomisation; diet/placebo run‐in for 4 weeks * AHA step 1 diet or similar instruction at baseline
Outcomes	LDL‐C: enzymatic method, calculated Friedewald's formula TC: enzymatic method HDL‐C: heparin‐manganese chloride method TG: enzymatic method
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization process by randomised numbers.
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: 6% Losses to follow‐up: 6% Missing from analysis: 0%
Selective reporting (reporting bias)	Unclear risk	No indication to suspect selective reporting.