Methods	Allocation: random, no further details. Blindness: double, identical capsules. Duration: 12 weeks. Design: parallel. Location: multicentre.
Participants	Diagnosis: schizophrenia (DSM-IV). N = 187. Sex: 113 M, 73 F (intent-to-treat group). Age: 18-65 years (mean ~ 36 years). History: duration ill unclear, age at onset unclear, at least moderately ill on CGI-S. Setting: inpatient and outpatient.
Interventions	Sertindole: flexible dose (permitted range 12-24 mg/day, mean 16.2). N = 98 Risperidone: flexible dose (permitted range 4-10 mg/day, mean 6.6). N = 89
Outcomes	Leaving study early: any reason, adverse effects, inefficacy. Global State: CGI. Mental State: PANSS (total, positive, negative sub-score). Functioning: GAF. Attitude: Drug attitude inventory. Adverse effect/event: at least one adverse effect, QTc prolongation, death, extrapyramidal side effects (tremor, AIMS, BAS, SAS), prolactin associated effects (amenorrhoea, sexual dysfunction), sedation, weight change
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, 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 lack of blinding
Incomplete outcome data addressed? All outcomes	High risk	Data on reasons for leaving the study early were available, but total number was considerably high (35.8%). 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 5% of the participants were reported. This procedure can miss rare, but important adverse events
Free of other bias?	High risk	The study was industry sponsored by the manufacturer of sertindole