Maahs 2006.

Methods	Parallel randomised controlled clinical trial, randomisation ratio: 1:1, superiority design
Participants	Inclusion criteria: aged 14 to 18 years BMI > 85th percentile for age and sex Exclusion criteria: known secondary causes for obesity (e.g. hypothyroidism, daily corticosteroid exposure > 30 days, history of significant exposure to corticosteroids for chronic illness during the past year and known genetic causes of obesity) Diagnostic criteria: see above
Interventions	Intervention: orlistat + diet and exercise therapy Control: placebo + diet and exercise therapy Number of trial centres: 1 Treatment before trial: none Titration period: no
Outcomes	Outcomes reported in abstract of publication: BMI reduction, adverse effects, laboratory measurements
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 evaluate the efficacy of orlistat to enhance weight loss in obese adolescents"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "The GCRC [General Clinical Research Center] statistician generated the randomization sequence before the start of the study" "Two sets of subjects (a sister‐sister pair and a girlfriend‐boyfriend pair) were assigned to the same cohort, as determined by the order of entry of the first member of the pair; the next paired subject was blocked into the same cohort and given the next available number in that cohort" Comment: not all participants were randomised
Allocation concealment (selection bias)	Low risk	Quote: "The list of randomization assignments was sealed and sent to the study pharmacist, who had no contact with study subjects" Comment: allocation was concealed
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Quote: "Only the research pharmacist was aware of treatment status" Comment: participants and personnel were blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	Low risk	Quote: "Only the research pharmacist was aware of treatment status" Comment: participants and personnel were blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: "Only the research pharmacist was aware of treatment status" Comment: participants and personnel were blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Quote: "Only the research pharmacist was aware of treatment status" Comment: participants and personnel were blinded
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: an imputation method was not used to replace missing data; however, dropout was fairly low
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: unable to access effect on subjective outcomes as quality of life results were not reported
Selective reporting (reporting bias)	High risk	Comment: results from the quality of life questionnaires were not reported
Other bias	Unclear risk	Comment: unclear if any other bias exists