Chanoine 2005.

Methods	Parallel randomised controlled clinical trial, randomisation ratio 2:1 (orlistat: placebo), superiority design
Participants	Inclusion criteria: adolescents (aged 12 to 16 years) were eligible for enrolment if they: had a BMI (calculated as weight (kg) divided by height squared (m2)) ≥ 2 units than the US weighted mean for the 95th percentile based on age and sex had a parent or guardian prepared to attend trial visits with them were willing to be actively involved in behavioural modification Exclusion criteria: BMI ≥ 44 (to increase homogeneity of the group) bodyweight ≥ 130 kg or < 55 kg weight loss ≥ 3 kg within 3 months prior to screening diabetes requiring antidiabetic medication obesity associated with genetic disorders history or presence of psychiatric disease use of dexamphetamine or methylphenidate active gastrointestinal tract disorders ongoing bulimia or laxative abuse use of anorexiants or weight‐reduction treatments during the 3 months before randomisation Diagnostic criteria: see above
Interventions	Intervention: orlistat + diet + exercise + behaviour therapy Comparator: placebo + diet + exercise + behaviour therapy Number of trial centres: 32 Treatment before trial: no Titration period: no
Outcomes	Outcomes reported in abstract of publication: BMI, weight, fat mass (DEXA), waist circumference, adverse events
Study details	Run‐in period: placebo was given for 2 weeks before treatment began in the intervention group Trial terminated early: no
Publication details	Language of publication: English Commercial funding Publication status: peer‐reviewed journal
Stated aim for study	Quote from publication: "To determine the efficacy and safety of orlistat in weight management of adolescents"
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomized centrally according to a computer‐generated randomization schedule prepared by the study’s sponsor, with stratification by body weight (<80 kg or ≥80 kg) on day 1 and by weight loss during the lead‐in period (<1 kg or ≥1 kg)" Comment: an adequate randomisation method was used
Allocation concealment (selection bias)	Low risk	Quote: "The allocation process was triple‐blind; the allotted treatment group was obtained through an automated telephone system" Comment: allocation concealment was sufficient to protect against bias
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Quote: "double‐blind study" Comment: the author confirmed all participants, trial personnel and outcome assessors were blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	Low risk	Quote: "double‐blind study" Comment: the author confirmed all participants, trial personnel and outcome assessors were blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: "double‐blind study" Comment: the author confirmed all participants, trial personnel and outcome assessors were blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Quote: "double‐blind study" Comment: the author confirmed all participants, trial personnel and outcome assessors were blinded
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: even though an imputation method was used (LOCF), dropout rates were high. Effect on objective outcomes unclear
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: even though an imputation method was used (LOCF), dropout rates were high. Effect on subjective outcomes unclear
Selective reporting (reporting bias)	Unclear risk	Comment: unable to assess if all outcomes were reported due to the trial protocol not previously been published
Other bias	Unclear risk	Quote: "Hoffmann‐La Roche was involved in the study design and conduct and in the analysis and interpretation of the data. All data were independently reanalyzed by an academic statistician" Comment: potential influence from the funding body (Hoffmann‐La Roche). No rationale to explain the imbalance in the number of participants in the 2 groups