Statistical Analysis
hallucinatory behavior, delusions, PSP
REMISSION, RELAPSE
No formal sample size determination was performed for this study. The sample size was determined by the number of participants who completed the DB study without relapse and were willing to participate in this OLE.Efficacy and safety analyses were conducted on an intent-to-treat analysis set, which included all participants who received ≥1 dose of the study medication. Descriptive statistics (mean, SD, median, range [minimum and maximum]) were provided for the CGI-S, PSP, and PANSS over time, including all assessment time points from the baseline of the DB phase to the end of study or early withdrawal visit of this OLE study.Relapse rates and number and percentage of participants achieving symptomatic remission were summarized at month 12, month 24, and at the end of study or early withdrawal visit. For single observations, transitory symptomatic remission was defined as having a simultaneous score of mild or less (≤3 points) on the following 8 items from the PANSS: the positive-symptom items P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior); the negative symptom items N1 (blunted affect), N4 (social withdrawal), and N6 (lack of spontaneity); and the general-psychopathology items G5 (mannerisms/posturing) and G9 (unusual thought content). TEAEs were summarized descriptively.