Kujawa 2002.

Methods	Allocation: randomised, method not described. Blindness: double. Duration: 52 weeks (preceded by variable washout period‐ >5 days). Design: parallel, active‐controlled prospective, dual study‐multicentre. Setting: out‐patient, USA and Europe. Consent: described. Loss: described.
Participants	Diagnosis: schizophrenia (DSM‐IV). N=1294. Age: 18‐65, average ˜37 years. Sex: male 758, female 536. History: acute relapse; baseline PANSS of >/=60 with >/=4 on any 2 psychotic items subscale; history of prior response to antipsychotic medication(other than clozapine); continuous outpatient treatment for at least 3 months in the past year; non‐pregnant, non‐lactating women and men; medically stable on physical examination, ECG,routine laboratory testing. Exclusions: pregnancy and lactation, treatment resistance, suicidal ideation/risks, first episode of schizophrenia, other psychiatric or neurological disorder, substance dependence, concomitant medication that might interfere with metabolism or analysis, participants in previous aripiprazole study or used an investigational medication within 4 weeks.
Interventions	1. Aripiprazole: dose 30 mg/day, with possibility of one‐off dose decrease to 20 mg for tolerability. N=861. 2. Haloperidol: dose 5 mg/day for days 1‐3; dose 10 mg/day from day 4 onwards; with possibility to decrease to 7 mg for tolerability. N=433.
Outcomes	Global state: discontinuation due to lack of efficacy, adverse event, marked deterioration. Engagement with services: discontinuation due to lack of compliance(>60% discontinuation rate). Leaving the study early. Death. Unable to use ‐ Global state: CGI score (no usable data, >60% discontinuation rate). Mental state: PANSS total score, PANSS negative subscale score, MADRAS total score, PANSS depression item, PANSS depression/anxiety cluster, PANSS negative subscale score (no usable data/SDs, >60% discontinuation rate). Adverse effects: SAS, BAS, AIMS; specific symptoms; changes in body weight, serum prolactin levels, vital signs; ECG changes (>60% discontinuation rate). Economic outcomes: concomitant medication (>60% discontinuation rate).
Notes	Greater than 60% discontinuation rate. Limited data on standard deviations given. Different patient numbers analysed for safety and efficacy. Data reported in both LOCF and OC analyses. Jadad=2.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear