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Letters Annals of Internal Medicine COMMENTS AND RESPONSES Treatment of Moderate to

By To The and Omized Trial Kimball


colleagues (1), which claims a benefit of adalimumab in hidradenitis suppurativa, raises numerous questions about its methodology history (2). First, although the authors state that the primary outcome was “prespecified, ” the trial’s history of changes on notes substantial alterations on 7 May 2011, more than 2 years after the trial began (3). Specifically, the primary outcome was altered on that date from an undefined “Physician’s Global Assessment ” to “Percentage of Participants Achieving Clinical Response at Week 16. ” Another primary outcome of “Adverse Events ” at a time point of week 52 was changed to “Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16.” A secondary end point of Physician’s Global Assessment at week 52 was changed to “Percentage of Participants Achieving Clinical Response at Week 8. ” A secondary outcome of “Nodule, Fistula and Abcess [sic] Improvement, ” which was not significantly improve

Year: 2013
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