SUBJECTS AND METHODS : STUDY DESIGN SUBJECTS The study was a double-blind, randomized, flexible-dose com- parison of sertraline and placebo for the treatment ofPTSD The subjects were male and female outpatients 18 years and in outpatients. After a I-week, single-blind, placebo run-in older who met period, subjects were randomized, using computer- of PTSD as determined by part 1 of the !=linician- generated random numbers, to 12 weeks of double-blind,

doi:10.4324/9780203825266-126

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ABSTRACT

The incidence of adverse events, the percentage of subjects who discontinued because of adverse events, and the incidence of clinicaUy significant laboratory abnormalities were compared between treatment groups using Fisher exact test. Changes in vital signs (blood pressure, heart rate, and body weight) were compared for the 2 treatment groups using the Wilcoxon rank-sum test.