Fleischhacker 2008.

Methods	Allocation: random, no further details. Blindness: double, no further details. Duration: 52 weeks (first six weeks observed). Design: parallel. Location: multicentre.
Participants	Diagnosis: (DSM‐IV) acute schizophrenia, PANSS of 60 or more. N = 703. Age: 18‐65 years. Gender: M, F. History: duration of illness not reported, age at onset not reported. Setting: in‐ and out‐patient.
Interventions	1. Aripiprazole: flexible dose. Allowed dose range: 15‐30 mg/day. N = 355. 2. Olanzapine: flexible dose. Allowed dose range: 10‐20 mg/day. N = 348.
Outcomes	Leaving the study early: any reason. Global state: CGI. Mental state: PANSS total score, MADRS. Quality of life/satisfaction with treatment: Quality of Life Enjoyment and Satisfaction Questionnaire, Medication adherence scale. Adverse effects: open interviews, EPS (SAS, AIMS, BAS), cardiac effects (ECG), weight gain (BMI). Unable to use ‐ Adverse event outcomes (no data, interim report)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	1:1 randomisation using SARA (System for Automated Randomisation). QTONE an automated touch tone system was used. Statistical blocking factor of four was used and stratified by the study centre.
Allocation concealment (selection bias)	Unclear risk	No further details.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double, no further details. Whether blinding was successful has not been examined, but both compounds differ quite substantially in adverse effects. This can be a problem for blinding.
Blinding of outcome assessment (detection bias) All 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 (attrition bias) All outcomes	High risk	Leaving the study early data within the first six weeks were 25% overall, but data on reason for dropout were not available. The LOCF method was used to account for people leaving the study early.
Selective reporting (reporting bias)	High risk	Data for the predefined primary outcome are available but secondary outcome measures like 30% PANSS total reduction are missing in the six‐week interim report. Treatment emergent adverse events are hardly addressed in the interim report.
Other bias	High risk	The study was industry sponsored by the manufacturer of aripiprazole. Baseline data reporting is insufficient in terms of missing data on history of illness.