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Randomised controlled non-inferiority trial.
Eight weeks (treatment period only).
66 centres, USA; enrolment June 2001 to September 2002.
673 adults (aged 18–65 years) with DSM-IV schizophrenia. Inclusion criteria: Positive and Negative Syndrome Scale (PANSS) total score ⩾60; score ⩾4 on delusions, conceptual disorganisation, hallucinations, suspiciousness, or persecution PANSS items; Clinical Global Impression Scale Severity of Illness score ⩾4; and evidence of deterioration in the 3 weeks prior to randomisation. Exclusions: other DSM-IV axis I disorder; intolerance or previous non-response to study drugs; use of clozapine in last month; psychotic …
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