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[Correspondence] The CHAMPION trial outcomes were not adequately prespecified

The publication from William Abraham and colleagues (Jan 30, p 453)1 reports eight outcomes that were not appropriately prespecified in the trial registry (NCT00531661) or in the Article reporting the study design.2 Trial recruitment began in September, 2007, and ended in October, 2009. There was a randomised study period that finished in August, 2010, followed by an open access period that finished in April, 2012.1 In December, 2008, one primary efficacy outcome was specified in the trial registry, followed by the addition of two primary safety outcomes and four secondary outcomes in April, 2013.