Methods	Allocation: random, permuted block randomisation stratified by centre. Blindness: double, identical capsules. Duration: 4 weeks. Design: parallel. Location: multicentre.
Participants	Diagnosis: (DSM-IV) schizophrenia (n = 80) or schizoaffective disorder (n = 3), acute relapse. PANSS total score of 60 or more. N = 83. Age: 18-65 years (mean aripiprazole = 35.2 years, mean risperidone = 35.1 years). Sex: 45 M, 38 F. History: duration illness not reported, age at onset not reported. Setting: inpatient.
Interventions	Aripiprazole: fixed dose: 15 mg/day. N = 49. Risperidone: fixed dose: 6 mg/day. N = 34.
Outcomes	Leaving the study early: any reason, adverse events, inefficacy. Global State: CGI. Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore. Adverse effects: at least one adverse effect, cardiac effects (QTc), extrapyramidal side effects (use of antiparkinson medication, extrapyramidal symptoms, AIMS, BAS, SAS), cholesterol increase, glucose elevation, prolactin increase, weight
Notes
Risk of bias
Bias	Authors’ judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Random, permuted block randomisation stratified by centre.
Allocation concealment?	Unclear risk	No further details.
Blinding? subjective outcomes	Unclear risk	Double, identical capsules. Whether blinding was successful has not been examined, but both compounds differ quite substantially in side effects. This can be a problem for blinding
Blinding? objective outcomes	Low risk	Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding
Incomplete outcome data addressed? All outcomes	Unclear risk	Total number of participants leaving the study early was possibly acceptable (25%). The LOCF method was used to account for people leaving the study early. It assumes that a participant who discontinued the study would not have had a change of his condition if he had remained in the study. This assumption can obviously be wrong. It is unclear whether this led to bias
Free of selective reporting?	High risk	Only adverse events with an incidence of at least 5% in any treatment group were reported, therefore important side effects may have been missed by this procedure
Free of other bias?	High risk	The study was industry sponsored by the manufacturer of aripiprazole