Participant Disposition and Baseline Characteristics
ADVERSE EVENTS, POSITIVE
A total 618 of 702 participants completed the DB study and 571 participants completed the 12-month DB phase without a relapse. In the centers where the open label study was conducted, 178 participants without relapse elected to continue the treatment and enter the OLE study. Of these participants, 154 (86.5%) completed the 2-year OLE study (Participant Demographics and Baseline CharacteristicsAbbreviations: BMI, body mass index; CGI-S, Clinical Global Impression-Severity; DB, double-blind; PANSS, Positive and Negative Symptom Scale; PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation; PSP, Personal and Social Performance.


The mean (SD) duration of exposure was 682.1 (150.8) days, and the mean (SD) dose was 875.7 (140.15) mg eq. Most participants (158 participants [88.8%]) received all 4 doses of PP6M. Overall, 24 (13.5%) participants withdrew before study completion, with withdrawal by participant (7.9%) and adverse events (3.9%) being the common reasons for discontinuations.