Ozkan 2004.

Methods	Parallel randomised controlled clinical trial, randomisation ratio 1:1, superiority design
Participants	Inclusion criteria: severe exogenous obesity, described as weight for height index > 140% in otherwise healthy participants, not associated with endocrinopathy, genetic syndromes or medications adolescents (Tanner stage 2 or higher) aged 10 to 16 years, and informed consent for the trial Exclusion criteria: ‐ Diagnostic criteria: see above
Interventions	Intervention: conventional treatment + orlistat Control: conventional treatment Number of trial centres: 1 Treatment before trial: no Titration period: no
Outcomes	Outcomes reported in abstract of publication: adverse effects, bodyweight loss, % bodyweight lost, BMI
Study details	Run‐in period: no Trial terminated early: no
Publication details	Language of publication: English Noncommercial funding Publication status: peer‐reviewed journal
Stated aim for study	Quote from publication: "To investigate the efficacy and tolerability of orlistat in obese adolescents, a prospective, open‐label, randomised, controlled pilot trial was performed"
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "Randomisation was done by alternation of successive patients, who met the inclusion criteria, to receive conventional treatment alone or orlistat in addition to conventional treatment" Comment: an inappropriate randomisation method was used
Allocation concealment (selection bias)	High risk	Comment: allocation was likely not concealed due to the randomisation method used
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Quote: "the true benefit of orlistat versus conventional therapy remains to be determined in a larger placebo‐controlled study" Comment: the control group did not receive a placebo therefore could not have been blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote: "the true benefit of orlistat versus conventional therapy remains to be determined in a larger placebo‐controlled study" Comment: the control group did not receive a placebo therefore could not have been blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Unclear risk	Comment: unclear if outcome assessors were blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Comment: unclear if outcome assessors were blinded
Incomplete outcome data (attrition bias) Objective outcomes	High risk	Comment: an imputation method to replace missing data were not performed, and dropout rate was moderate
Incomplete outcome data (attrition bias) Subjective outcomes	High risk	Comment: an imputation method to replace missing data were not performed, and dropout rate was moderate
Selective reporting (reporting bias)	Unclear risk	Comment: BMI was reported in different formats; median BMI at baseline and mean BMI at follow‐up. No protocol published
Other bias	High risk	Comment: there were significant differences in baseline BMI between groups which were not accounted for. A power calculation was not performed, therefore trial may have been underpowered