Asadabadi 2013.

Study characteristics
Methods	Parallel, placebo‐controlled trial of celecoxib + risperidone versus placebo + risperidone
Participants	Inclusion criteria: children aged 4‐12 years met DSM‐4‐TR criteria for diagnosis of ASD ABC‐C‐I score of ≥ 15 Exclusion criteria: previously received neuroleptics or any psychotropic drug treatment 6 months prior to recruitment significant active medical problem severe or profound intellectual disabilities in whom a definitive diagnosis of autism could not be made any diagnosis of psychiatric disorder in Axis I and II any organic disorder Location/setting: children's outpatient clinic at Roozbeh hospital, Tehran, Iran Sample size: 40 Number of withdrawals/dropouts: none reported Gender: 25 boys, 15 girls Mean age: celcoxib = 7.6 (1.7) years; placebo = 7.5 (1.5) years IQ: not reported Baseline ABC‐I scores or other BoC scale: celecoxib = 17.3; placebo = 17.6 Concomitant medications: not reported History of previous medications: celecoxib + risperidone: 19/20 had previously taken risperidone, 1/20 had taken haloperidol previously; placebo + risperidone: 18/20 had taken risperidone previously, 2/20 had taken haloperidol previously
Interventions	Intervention (celecoxib + risperidone) for 10 weeks: celecoxib (100 mg capsules) titrated up to 200 mg/day for children weighing < 30 kg and 300 mg/day for > 30 kg. Risperidone (0.5 mg tablets) was titrated up to 2 mg/day (starting dose of 0.5 mg with subsequent dose increase in 0.5 mg increments in the weekly dosage for the first 3 weeks) for children between 10 kg and 40 kg and 3 mg/day for children weighing above 40 kg Comparator (placebo + risperidone) for 10 weeks: placebo not described. Risperidone (0.5 mg tablets) was titrated up to 2 mg/day (starting dose of 0.5 mg with subsequent dose increase in 0.5 mg increments in the weekly dosage for the first 3 weeks) for children between 10 kg and 40 kg and 3 mg/day for children weighing above 40 kg
Outcomes	Primary outcomes Irritability, measured using the ABC‐I subscale (Aman 1985) at baseline and weeks 2, 4, 6 and 10 AEs, recorded every 2 weeks Secondary outcome: none reported
Notes	Study start date: November 2009 Study end date: January 2012 Funding source: grant from Tehran University of Medical Sciences to Prof Shahin Akhondzadeh (grant No:. 8144) Conflict of interest: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomized in a 1:1 ratio using a computer‐generated code"
Allocation concealment (selection bias)	Low risk	Quote: "The assignments were kept in sealed, opaque envelopes until data analysis". "Separate persons were responsible for random allocation and interviewing the patients."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Throughout the study, the person who administered the medications, the rater, and the patients and their parents were blind to assignments".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Throughout the study, the person who administered the medications, the rater, and the patients and their parents were blind to assignments".
Incomplete outcome data (attrition bias) All outcomes	Low risk	No LTFU reported. All children included in the analysis. Quote: "All patients completed the trial and there were no missing data."
Selective reporting (reporting bias)	Low risk	The ABC was reported at baseline and weeks 2, 4, 6, 8 and 10.
Other bias	High risk	Study was reduced from 10 weeks to 8 weeks and the contact author is also on the ethics committee at the university funding the study the contact author is a peer‐reviewer for one of the journals in which some of their studies are published.