Derivative studies of the PREDIMED Trial were published in 4 articles1,2,3,4 in JAMA Internal Medicine between 2007 and 2015. After publication of these articles, protocol deviations were discovered that were addressed in reanalyses and that require corrections to these 4 articles. A Letter of Explanation5 describes the reanalyses and corrections. These articles have been corrected online.
References
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