Miral 2008.

Study characteristics
Methods	Parallel trial of risperidone versus haloperidol
Participants	Inclusion criteria: meet DSM‐4 criteria for ASD age 8–18 years have parents’ informed consent agree to be followed‐up antianalgesics, antipyretics, decongestants and antibiotics were allowed during the trial participants with extrapyramidal symptoms could use anticholinergics, but prophylactic use was discouraged Exclusion criteria: epilepsy had a concomitant neuropsychiatric illness (such as ADHD, Tourette's syndrome etc), or demonstrated a psychotic disorder or symptoms, or had other PDDs benzodiazapines and other sedatives were not allowed Location/setting: Turkey Sample size: 30 (15 in each group) Number of withdrawals/dropouts: 2 in risperidone group excluded from final analysis from the week 12 evaluation because of the lack of efficacy data Gender: risperidone 11/15 male; haloperidol 13/15 male Mean age: risperidone 10 years, haloperidol 10.9 years IQ: not reported Baseline ABC‐I or other BoC: irritability (using the RFRLRS) risperidone 1.09, haloperidol 1.05 Concomitant medications: details not provided History of previous medications: details not provided
Interventions	Intervention (risperidone) for 12 weeks: risperidone was initiated at a dosage of 0.01 mg/kg/day and the dosage was increased to 0.04 mg/kg/day until the end of the 2nd week. If tolerated, then it was increased to a maximum dosage of 0.08 mg/kg/day. Mean daily dose 2.6 mg/day or maximum 0.08 mg/kg; haloperidol mean dose 2.6 mg/day Comparator (haloperidol) for 12 weeks: haloperidol was initiated at a dosage of 0.01 mg/kg/day and the dosage was increased to 0.04 mg/kg/day until the end of the 2nd week. If tolerated, then it was increased to a maximum dosage of 0.08 mg/kg/day.
Outcomes	Primary outcomes: irritability, measured using the RFRLRS ‐ Affectual Responses scale (Freeman 1986) AEs Secondary outcomes: none reported Timing of outcome assessments: baseline, weeks 2, 4, 8 and 12
Notes	Study start date: not reported Study end date: not reported Source of funding: "this research was supported in part by Janssen and Cilag Drug company". Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Details not provided
Allocation concealment (selection bias)	Unclear risk	Details not provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Details not provided
Blinding of outcome assessment (detection bias) All outcomes	High risk	Blinding not discussed Quote: "two experienced clinicians performed all of the measures"
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "two subjects who were being administered risperidone were excluded from our final analysis from the week 12 evaluation because of lack of efficacy data" LTFU: 2 in risperidone group were excluded from analysis due to lack of efficacy data ITT analysis or LOCF not noted by study authors
Selective reporting (reporting bias)	High risk	RFRLRS subscores and weight were outlined for both baseline and endpoint, as well as other outcomes reported in the paper. However, the CGI baseline scores were not reported despite being a primary outcome measure.
Other bias	Unclear risk	The research was supported in part by Janssen and Cilag Drug Company.