Study Design and Participants
schizophrenia
DISORDERS, POSITIVE, AIDS, POLAND, SYNDROME, MAY
This single-arm OLE study was conducted between September 2019 and May 2022 in 6 (Argentina, Hong Kong, Italy, Poland, Russia, and Ukraine) of the 20 countries that had previously participated in the DB noninferiority study. Eligible participants (aged 18–70 years with a diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, 5th edition for ≥6 months before screening and a Positive and Negative Syndrome Scale [PANSS] total score <70 points at screening; Study design of the double-blind study and open-label extension study. For additional analysis of safety and efficacy, OLE participants were categorized into 2 subgroups, PP3M/PP6M and PP6M/PP6M, indicating participants who had received PP3M and those who received PP6M in the DB study before the OLE.The concomitant use of anti-extrapyramidal symptom medications, benzodiazepines, sleep aids, and oral antipsychotics were allowed during the OLE. The duration and dose of antipsychotic supplementation was dependent on symptom exacerbation and per the investigator’s judgment (supplementary 