This group will hereafter be referred to as the 150/100mgeq arm. Data from the Gamma-secretase inhibitor overall study population were provided as a reference where appropriate [Pandina et al. 2010]. Frequencies, percentages, and descriptive statistics were used to summarize demographic and clinical characteristics as well as tolerability and efficacy variables. AEs reported during days 1–7 were summarized Inhibitors,research,lifescience,medical for those reported

in ≥2% of patients receiving paliperidone palmitate (included all three paliperidone palmitate treatment arms) and in a higher percentage of patients receiving paliperidone palmitate than placebo. At day 8, those assigned to paliperidone palmitate received their assigned fixed dose with approximately one-third being assigned to the 100mgeq (156mg) treatment arm. Because Inhibitors,research,lifescience,medical of this substantially lower total number of patients, AEs reported during

days 8–36 were summarized for those reported in ≥5% of patients receiving paliperidone palmitate and in a higher percentage of patients receiving paliperidone palmitate than placebo. Changes in weight and reports of prolactin-related and movement disorder-related events that occurred over the entire study period were summarized. AEs are presented in two panels – incidence by Inhibitors,research,lifescience,medical treatment group and relative risk (RR) with 95% confidence intervals (CIs) of an event in the active group relative to the placebo group. A RR was considered potentially significant when its 95% CI did not include 1. For AEs with an incidence of zero in one group, a correction of 0.5 Inhibitors,research,lifescience,medical was used in the logit estimator in calculating the RR. No adjustment was made for multiplicity. An analysis of covariance (ANCOVA) model with effects of treatment, country, and Inhibitors,research,lifescience,medical baseline value without adjustment for multiple comparisons assessed between-group

changes for continuous measures. The last-observation-carried-forward (LOCF) approach was utilized. Effect sizes (treatment versus placebo) were calculated using Cohen’s d based on the change from baseline in least-squares (LS) mean PANSS total score, mean CGI-S score, and mean PSP score at endpoint. Results Randomization, completion, and characteristics Of 855 patients screened, 652 (76.3%) were randomized, and those 636 (476 assigned to paliperidone palmitate and 160 to placebo) comprised the ITT overall study population analysis set. In the ITT analysis set, 146 were diagnosed within the prior 5years and were classified as the recently diagnosed subgroup (Figure 1). Figure 1. Subject randomization and completion in intent-to-treat (ITT) study populations: overall population and recently diagnosed subgroup. In the recently diagnosed subgroup, discontinuation rates due to adverse events were 10.3% (4 of 39) with paliperidone …