Author Contributions: Dr Albert 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: Albert, Gaziano, Manson.
Acquisition of data: Albert, Gaziano, Zaharris, MacFadyen, Danielson, Buring, Manson.
Analysis and interpretation of data: Albert, Cook, Manson.
Drafting of the manuscript: Albert.
Critical revision of the manuscript for important intellectual content: Albert, Cook, Gaziano, Zaharris, MacFadyen, Danielson, Buring, Manson.
Statistical expertise: Cook.
Obtained funding: Albert, Gaziano, Manson.
Administrative, technical, or material support: Zaharris, MacFadyen, Danielson, Manson.
Study supervision: Albert, MacFadyen, Danielson, Manson.
Financial Disclosures: Dr Gaziano reports receiving investigator-initiated study support of vitamin pills and packaging from Wyeth. 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. The other authors reported no disclosures.
Disclaimer: Dr Gaziano, a JAMA Contributing Editor, was not involved in the editorial review of or decision to publish this article.
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. 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.
Role of the Sponsor: Cognis, BASF, and the National Heart, Lung, and Blood Institute did not participate in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Data and Safety Monitoring Board: L. Cohen, R. Collins, T. Colton, D. DeMets, I.C. Henderson, A. La Croix, R. Prentice, and N. Wenger (chair) and M.F. Cotch, F. Ferris, L. Friedman, P. Greenwald, N. Kurinij, M. Perloff, E. Schron, and A. Zonderman (ex-officio members).
Additional Contributions: We are indebted to the 5442 participants in the Women's Antioxidant and Folic Acid Cardiovascular Study for their dedicated and conscientious collaboration; to the entire staff of the Women's Antioxidant and Folic Acid Cardiovascular Study: including Marilyn Chown, BS, MPH, Shamikhah Curry, Margarette Haubourg, Felicia Zangi, Tony Laurinaitis, Geneva McNair, Philomena Quinn, Harriet Samuelson, MA, Ara Sarkissian, MM, and Martin Van Denburgh, BA; and to the following individuals for their assistance in conducting this trial: Michelle Albert, MD, MPH, Tobias Kurth, MD, ScD, I-Min Lee, MBBS, ScD, Aruna Pradhan, MD, MPH, Paul Ridker, MD, MPH, and Jacqueline H. Suk, MD, MPH, Brigham and Women's Hospital, Boston, Massachusetts; Gavin Blake, MBBS, Mater Misericordiae University Hospital, Dublin, Ireland; Claudia Chae, MD, MPH, Massachusetts General Hospital, Boston; Carlos Kase, MD, Boston University Medical Center, Boston, Massachusetts; and James O. Taylor, MD, East Boston Neighborhood Health Center, Boston, Massachusetts.