Daniel 2000.

Methods	Allocation: randomised, method not described. Blindness: double. Duration: 4 weeks, preceded by 3‐7 day washout period. Design: parallel, multicentre, dose‐ranging. Setting: inpatient. Consent: not described. Loss: described.
Participants	Diagnosis: schizophrenia (DSM‐IV). N=307. Age: 18‐65 years, average ˜38. Sex: male 247, female 60. History: acute relapse, BPRS score >36 & score of > 4 on 2 criteria, no antipsychotic medication taken for >72 hours prior to randomisation(4 weeks for a long‐acting agent). Exclusions: first episode of schizophrenia; refractory to conventional antipsychotics; moderate to severe EPS, dyskinesia or akathisia; substance abuse or dependence; cardiac disease; acute or unstable medical condition; pregnancy, lactation, women not using adequate contraception.
Interventions	1. Aripiprazole: dose 2 mg/day. N=59. 2. Aripiprazole: dose 10 mg/day. N=60. 3. Aripiprazole: dose 30 mg/day. N=61. 4. Haloperidol: dose 10 mg/day after 5mg/day 1+2). N=63. 5. Placebo. N=64.
Outcomes	Leaving the study early. Unable to use ‐ Global state: CGI score (no SDs); >40% discontinuation rate. Mental state: BPRS score (no SDs); >40% discontinuation rate. General functioning: CGI (no SDs); >40% discontinuation rate. Adverse effects: reported adverse effects, extra‐pyramidal side effects, mean weight gain, mean prolactin levels (no usable data); >40% discontinuation rate. Economic outcomes: use of concomitant medication >40% discontinuation rate.
Notes	Over 40% overall discontinuation rate. No data given on standard deviations. Marked sex differential in participants. 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