Methods	Allocation: random, no further details. Blindness: double, no further details. Duration: 12 weeks. Design: parallel. Location: multicentre. Setting: not specified.
Participants	Diagnosis: schizophrenia (DMS-IV). N = 321. Sex: 250 M, 71 F. Age: 18-55 years (mean ~ 39). History: duration ill not specified, mean age at onset - 22 years, treatment resistance, PANSS total score ≧ 60
Interventions	Sertindole: flexible dose (permitted range 12-24 mg/day, mean 18.1). N = 216. Risperidone: flexible dose (permitted range 6-12 mg/day, mean 9). N = 105
Outcomes	Leaving study early: any reason, adverse events, inefficacy. Mental State: PANSS total score. Adverse effects/event: at least one adverse effect, QTc prolongation, cholesterol, extrapyramidal effects (akathisia, parkinsonism, AIMS, BAS, SAS), glucose, sexual dysfunction, sedation, weight
Notes
Risk of bias
Bias	Authors’ judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Random, no further details.
Allocation concealment?	Unclear risk	No further details.
Blinding? subjective outcomes	Unclear risk	Double, no further details. Whether blinding was successful has not been examined. Both compounds differ substantially in side effects which 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	High risk	Data on reason for drop-out were available but total numbers was considerably high (32.4%). 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
Free of selective reporting?	High risk	Only those adverse events that occurred in at least 10% of the participants were reported. This procedure can miss rare, but important adverse events
Free of other bias?	High risk	The study was sponsored by the manufacturer of sertindole.