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M. Martínez-González (2018)
Protocol Deviations and Reanalyses in Derivative Studies of the PREDIMED Trial.JAMA internal medicine, 178 12
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Letters 2. Correction: updated disclosure statement for invited commentary Henry T. Stelfox, MD, PhD [published online December 3, 2018]. JAMA Intern Med. doi:10.1001 Daniel J. Niven, MD, PhD /jamainternmed.2018.7305 Kirsten M. Fiest, PhD Author Affiliations: Department of Critical Care Medicine, Cumming School of Protocol Deviations, Reanalyses, and Corrections Medicine, University of Calgary, Calgary, Alberta, Canada (Stelfox, Niven, Fiest); to Derivative Studies of the PREDIMED Trial Department of Community Health Sciences, Cumming School of Medicine, To the Editor As reported elsewhere, my coinvestigators and University of Calgary, Calgary, Alberta, Canada (Stelfox, Niven, Fiest); O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, coauthors of the PREDIMED trial have identified protocol de- Calgary, Alberta, Canada (Stelfox, Niven, Fiest); Alberta Health Services, Calgary, viations, including enrollment of household members with- Alberta, Canada (Stelfox, Niven); Hotchkiss Brain Institute, Cumming School of out randomization, assignment to a study group without ran- Medicine, University of Calgary, Calgary, Alberta, Canada (Fiest). domization of some participants at 1 of 11 study sites, and Corresponding Author: Henry T. Stelfox, MD, PhD, McCaig Tower, University of apparent inconsistent use of randomization tables at another Calgary, 3134 Hospital Dr NW, Calgary, AB T2N 5A1, Canada (tstelfox@ucalgary.ca). site.
JAMA Internal Medicine – American Medical Association
Published: Dec 5, 2018
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