Dossenbach 1998.

Methods	Allocation: randomised, no further information. Blindness: double‐blind. Duration: Acute phase: 6 weeks (2 to 9 days placebo lead‐in); long term: 22 weeks. Setting: hospital, multicentre, Croatia. Design: parallel.
Participants	Diagnosis: schizophrenia or schizoaffective disorder (DSM‐IV) N = 60. Age: mean˜35.4 years, SD˜10.4 years. Sex: men = 28 and women = 32. Length of illness: not stated. Inclusion criteria: schizophrenia, BPRS ≥ 42, CGI ≥ 4 . Exclusion criteria: pregnant or lactating women, serious or unstable illness; history of intolerance to olanzapine; DSM substance dependence excluding caffeine or nicotine within last 30 days; serious suicide risk; significantly elevated liver function results; active hepatitis B or current jaundice; received treatment with injectable neuroleptic within less than one dosing interval between depot neuroleptic injection prior to study entry; previously intolerant or non‐responsive to fluphenazine; previous participation in any olanzapine clinical trial; pregnancy or lactating; uncorrected hypothyroidism or hyperthyroidism, myasthenia gravis, narrow‐angle glaucoma, chronic urinary retention and/or clinically significant prostatic hypertrophy, a history of seizures, severe allergies or multiple adverse drug reactions, a history of leukopenia without known aetiology.
Interventions	1. Fluphenazine: 5 mg to 20 mg/day, average, 11.7 ± 3.0 mg/day for acute phase (6 weeks) and 11.7 ± 3.0 mg/day for long term (22 weeks), n = 30. 2. Olanzapine: 6 mg to 21 mg/day, average, 13.6 ± 2.4 mg/day for acute phase (6 weeks) and 14.8 ± 2.5 mg/day for long term (22 weeks), n = 30.
Outcomes	Clinically important response: no clinical improvement*. Global state: CGI severity change score. Mental state: BPRS (global score; negative, positive change score); PANSS (total, positive, negative, general psychopathology change score), Hillside Akathisia Scale (HAS). Quality of Sleep scale: Leeds Sleep Evaluation Questionnaire (LSEQ) total and subscale score. Satisfaction: Drug Attitude Inventory (DAI). Extrapyramidal adverse effects: Simpson Angus Scale (SAS), and the Assessment of Involuntary Movements Scale (AIMS). Leave the study early. Unable to use: vital signs, ECG, laboratory findings, no data reported. HAMA subscale score. LSEQ in medium term, data not reported.
Notes	Funding: Eli Lilly and Company. *Two definitions: decreased rate of PANSS score < 40%, decreased rate of BPRS score < 40%.The data were reported separately in our data analysis based on these two definitions.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quotes: "Random allocation at a 1:1 ratio" (p.312)
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "This was a long‐term, randomised, double‐blind parallel clinical trial" (p.312)
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote:"This was a long‐term, randomised, double‐blind parallel clinical trial" (p.312)
Incomplete outcome data (attrition bias) All outcomes	High risk	Out of 60 participants, five (n = 3 olanzapine; n = 2 fluphenazine) were excluded from efficacy analysis because they did not meet inclusion criteria for BPRS or CGI. Three participants missing from DAI results because of no baseline data for two (n = 1 olanzapine; n = 1 fluphenazine) and one participant on fluphenazine discontinuing without having a DAI performed. Four participants in fluphenazine group discontinued because of adverse event. All participants were included in safety analysis.
Selective reporting (reporting bias)	Low risk	All measured outcomes were well reported.
Other bias	High risk	Funding: sponsored by Eli Lilly and Company.