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Figure 1 | Annals of General Psychiatry

Figure 1

From: Long-acting injectable paliperidone palmitate versus oral paliperidone extended release: a comparative analysis from two placebo-controlled relapse prevention studies

Figure 1

Designs of the two studies used in the analysis. A Paliperidone extended release (ER) vs placebo study. B Paliperidone palmitate (PP) vs placebo study. aSubjects remained in the double-blind phase until they experienced a relapse, until they withdrew from the study or until the study was completed. The double-blind phase was followed by an open-label extension in each study. Based on significant efficacy, both studies were terminated early. At the time the studies were stopped, a total of 91 subjects in the paliperidone ER study and a total of 76 subjects in the PP study were in the stabilisation phase and were considered as completing the entire study per protocol. Subjects (n = 25) in the PP study who did not meet the more stringent stabilisation criteria employed in the paliperidone ER study were excluded to standardise the study criteria. bSeven dropouts [1 adverse event (AE), 1 death, 2 lost to follow-up (FU) and 3 other]. cTwenty dropouts (12 withdrew consent, 3 AEs, 2 lost to FU, 1 study drug protocol violation and 2 other). dTwenty-seven dropouts (15 withdrew consent, 2 AEs and 10 other). eTwenty-nine dropouts (12 withdrew consent, 3 AEs and 14 other).

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