Caldato 2004.

Methods	RCT. Parallel design. Locaton: 2 tertiary centres in Brazil. Duration: 1 year.
Participants	44 participants randomly assigned to groups: Group 1 n = 23; Group 2 n = 21. Age, mean (range): Group 1, 9.4 (1.6 ‐ 20) years; Group 2, 8.3 (1.2 ‐ 21) years Gender split: Group 1, 16 females, 7 males; Group 2, 18 females, 3 males. Tanner stage: Group 1, 10 pre‐pubertal (B1 and G1, according to Tanner’s classification), 8 pubertal (B2‐B4 and G2‐G4), and 5 post‐pubertal (adults, B5 and G5); Group 2, 11 prepubertal, 5 pubertal and 5 post‐pubertal.
Interventions	Group 1: PD 2.4 ‐ 3.5 mg/m² BSA 1x daily. Group 2: HC 10 ‐ 15 mg/m² BSA 3x times daily. All participants received FC 0.1 mg/day.
Outcomes	Bone maturation ratio, height, weight, growth velocity, pubertal stage, plasma 17 OHP, androstenedione, serum testosterone and androstenedione values.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No mention of sequence generation.
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No mention of blinding of participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No mention of blinding of outcome assessors.
Incomplete outcome data (attrition bias) All outcomes	High risk	Attrition rate was not reported.
Selective reporting (reporting bias)	High risk	Did not have any access to the original trial protocols to definitely confirm this and we attempted to contact the investigators but did not receive a response. Not all outcome measures listed in the 'methods' section of the paper were fully reported in the results.
Other bias	Unclear risk	No other bias found.