Study Assessments
ideation, TEAEs, EPS, Extrapyramidal symptom, treatment-emergent adverse events
EVENTS
Efficacy endpoints included assessment of relapse events and change from baseline to the endpoint (Month 24) in PANSS (Safety was assessed by incidence of treatment-emergent adverse events (TEAEs; coded using Medical Dictionary for Regulatory Activities version 22.1), serious TEAEs, mental status examination, clinical laboratory tests, vital sign measurements, physical examinations, and evaluation of the injection site. The Columbia Suicide Severity Rating Scale was performed if suicidal ideation was identified during the mental status examination. Extrapyramidal symptom (EPS) rating scales and 12 lead electrocardiogram assessments were conducted at the investigator’s discretion. All clinical laboratory tests, including prolactin levels, were performed on fasted samples and were analyzed by a local laboratory.