Keks 2007.

Methods	Allocation: random. Blinding: open‐label. Duration: 12 months. Design: parallel. Setting: international, multi‐centre (48 centres in Australia, Belguim, France, Germany, Greece, Luxumbourg, Poland, Russia, Spain, The Netherlands and UK).
Participants	Diagnosis: schizophrenia or schizoaffective disorder (DSM‐IV). N = 629* (n = 11 not treated). Age: mean˜35 years, minimum 18 years. Sex: 312 M, 235 F. History: acute exacerbation of psychosis in previous 2 months and another episode during previous 2 years. Excluded: prior treatment with clozapine or depot antipsychotic. Included: PANSS total score > 50; at least 18 years of age; BMI not exceeding 40 mg/kg2. resistance or sensitivity to risperidone or olanzapine pregnant or breast feeding women, child bearing age women if not using contraception Consent: study protocol and amendments reviewed by independent ethics committees/ institutional review boards; conducted in accordance with Declaration of Helsinki and guidelines of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Written informed consent required.
Interventions	1. Risperidone depot: 25, 50 or 75 mg*, n = 318. 2. Oral olanzapine: 5‐20 mg/day, n = 300.
Outcomes	Mental state: PANSS. Specific adverse events; movement disorder; death and serious adverse events. Leaving the study early.
Notes	*After study initiation protocol was amended to restrict the doses of depot risperidone to 25 or 50 mg; 64 patients who had already received 75 mg of depot risperidone were withdrawn from the study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised, "using a central dynamic randomisation procedure. Randomisation was based on a minimisation algorithm that used a probability of assignment other than 0.5 to maintain balance of treatment groups within levels of each stratification factor" (p132). stratification factors of PANSS total score, number of previous psychiatric hospitalisations, BMI, inpatient or outpatient status, using a central dynamic randomisation procedure.
Allocation concealment (selection bias)	Low risk	Interactive voice response system (IVRS) used to obtain randomisation number.
Blinding (performance bias and detection bias) All outcomes	High risk	Open‐label study. No evidence of rater blinding.
Incomplete outcome data (attrition bias) All outcomes	High risk	N = 618 originally randomised and treated; n = 264 (42%) completed at 12 months. LOCF used for endpoint data including n = 361 participants (58%).
Selective reporting (reporting bias)	High risk	Protocol amended to restrict risperidone doses to 20 or 50 mg after investigators found that, quote, "75 mg doses provide no greater benefit than lower doses" (p132). The n = 64 participants receiving 75 mg doses completed the study, their data were withdrawn and they were invited to enrol in an open‐label extension study.
Other bias	High risk	Funding: "M.I., A.K. and K.K. are employees of Johnson & Johnson... study was supported by Johnson & Johnson Pharmaceutical Research and Development" (p138).