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Sertraline and Depression in Children—Reply
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In Reply: In response to Dr Garland, our combined analysis was defined a priori, well before the last participant was entered into the study and before the study was unblinded. The decision to present the combined analysis as a primary analysis and study report was made based on considerations involving use of the Children's Depression Rating Scale (CDRS) in a multicenter study. Prior to initiation of the 2 pediatric studies, the only experience with this scale in a study of selective serotonin reuptake inhibitors was in a single-center trial.1 It was unclear how the results using this scale in a smaller study could inform the power evaluation of the sample size for the 2 multicenter trials. The combined analysis reported in our article, therefore, represents a prospectively defined analysis of the overall study population. The results of the 24-week, open-label extension study, as well as an analysis of results of . . . [Full Text of this Article]
Karen Dineen Wagner, MD, PhD
University of Texas Medical Branch
Galveston
Christopher J. Wohlberg, MD, PhD;
Ruoyong Yang, PhD
Pfizer Inc
New York, NY
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