Author Contributions: Dr Zhang had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Zhang, Cook, Albert, Gaziano, Manson.
Acquisition of data: Gaziano, Manson.
Analysis and interpretation of data: Zhang, Cook, Buring, Manson.
Drafting of the manuscript: Zhang.
Critical revision of the manuscript for important intellectual content: Zhang, Cook, Albert, Gaziano, Buring, Manson.
Statistical analysis: Zhang, Cook.
Obtained funding: Albert, Gaziano, Manson.
Administrative, technical, or material support: Manson.
Study supervision: Zhang, Gaziano, Manson.
Financial Disclosures: Dr Gaziano reports receiving investigator-initiated study support of vitamin pills and packaging from Wyeth and investigator-initiated research support from BASF Corporation. Dr Buring reports receiving investigator-initiated study support of vitamin pills and packaging from Natural Source Vitamin E Association. Dr Manson reports receiving investigator-initiated study support of vitamin pills and packaging from Cognis and BASF Corporations. No other authors reported any financial disclosures.
Funding/Support: This study was supported by investigator-initiated grant HL47959 from the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr Zhang is in part supported by research scholar grant RSG-06-263-01-CCE from the American Cancer Society. Vitamin E and its placebo were supplied by Cognis Corporation (LaGrange, Illinois). All other agents and their placebos were supplied by BASF Corporation (Mount Olive, New Jersey). Pill packaging was provided by Cognis and BASF Corporations.
Role of the Sponsors: Cognis Corporation, BASF Corporation, the National Heart, Lung, and Blood Institute, and the American Cancer Society did not participate in the design and conduct of the study; in the collection, management, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Data and Safety Monitoring Board: Lawrence Cohen, MD, Rory Collins, FMed Sci FRCP, Theodore Colton, ScD, David DeMets, PhD, I. Craig Henderson, MD, Andrea La Croix, PhD, Ross Prentice, PhD, and Nanette Wenger, MD (chair), and Mary Frances Cotch, PhD, Frederick Ferris, MD, Lawrence Friedman, MD, Peter Greenwald, MD, DrPH, Natalie Kurinij, PhD, Marjorie Perloff, MD, Eleanor Schron, MS, RN, and Alan Zonderman, PhD (ex-officio members).
Disclaimer: Dr Gaziano, a contributing editor to JAMA, did not participate in the editorial review of this article or the decision to publish it.
Additional Contributions: We thank the 5442 dedicated WAFACS participants. The WAFACS staff, including Elaine Zaharris, BA, Jean MacFadyen, BA, Eleanor Danielson, MIA, Shamikhah Curry, Margarette Haubourg, Tony Laurinaitis, Geneva McNair, Philomena Quinn, Harriet Samuelson, MA, Ara Sarkissian, MM, and Martin Van Denburgh, BA, provided invaluable contributions. Natalya Gomelskaya, MD, and Rimma Dushkes, PhD (Brigham and Women's Hospital, Boston, Massachusetts), provided statistical analytical support. The end points reviewers, including Wendy Chen, MD, MPH, and I-Min Lee, MBBS, ScD (Brigham and Women's Hospital, Boston, Massachusetts), and James O. Taylor, MD (East Boston Neighborhood Health Center, Boston, Massachusetts), provided assistance with the trial. No one named above received any compensation for their contribution.