Published Online: October 17, 2012. doi:10.1001/jama.2012.14641
Author Contributions: Drs Gaziano and Sesso had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analyses. Drs Gaziano and Sesso contributed equally to this manuscript.
Study concept and design: Gaziano, Sesso, Christen, Manson, Glynn, Buring.
Acquisition of data: Gaziano, Sesso, Christen, Bubes, Smith, MacFadyen, Schvartz, Manson, Glynn, Buring.
Analysis and interpretation of data: Gaziano, Sesso, Christen, Bubes, Manson, Glynn, Buring.
Drafting of the manuscript: Gaziano, Sesso.
Critical revision of the manuscript for important intellectual content: Gaziano, Sesso, Christen, Bubes, Smith, MacFadyen, Schvartz, Manson, Glynn, Buring.
Statistical analysis: Gaziano, Sesso, Bubes, Glynn.
Obtained funding: Gaziano, Sesso, Buring.
Administrative, technical, or material support: Gaziano, Sesso, Bubes, Smith, MacFadyen, Schvartz, Manson, Glynn.
Study supervision: Gaziano, Sesso, Bubes, Smith, MacFadyen, Glynn.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Gaziano reported receiving investigator-initiated research funding from the National Institutes of Health (NIH), the Veterans Administration, and the BASF Corporation; assistance with study agents and packaging from BASF Corporation and Pfizer (formerly Wyeth, American Home Products, and Lederle); and assistance with study packaging provided by DSM Nutritional Products Inc (formerly Roche Vitamins). Dr Sesso reported receiving investigator-initiated research funding from the NIH, the Tomato Products Wellness Council, and Cambridge Theranostics Ltd. Dr Christen reported receiving research funding support from the NIH, Harvard University (Clinical Nutrition Research Center), and DSM Nutritional Products Inc (formerly Roche Vitamins). Dr Manson reported receiving investigator-initiated research funding from the NIH, and assistance with study pills and packaging from BASF and Cognis Corporations for the Women's Antioxidant and Folic Acid Cardiovascular Study and from Pronova BioPharma and Pharmavite for the VIT amin D and Omeg A-3 Tria L, and funding from the nonprofit Aurora Foundation. Dr Glynn reported receiving investigator-initiated research funding from the NIH, Bristol-Meyers Squibb, AstraZeneca, and Novartis; and signed a consulting agreement with Merck to give an invited talk. Dr Buring reported receiving investigator-initiated research funding from the NIH, and assistance with study pills and packaging from Natural Source Vitamin E Association and Bayer Healthcare for the Women's Health Study. No other authors reported any financial disclosures.
Funding/Support: This work was supported by grants CA 097193, CA 34944, CA 40360, HL 26490, and HL 34595 from the NIH and an investigator-initiated grant from BASF Corporation. Study agents and packaging were provided by BASF Corporation and Pfizer (formerly Wyeth, American Home Products, and Lederle) and study packaging was provided by DSM Nutritional Products Inc (formerly Roche Vitamins).
Role of the Sponsors: The NIH, BASF Corporation, Pfizer, and DSM Nutritional Products Inc had no role in the study 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: Voting members over the course of the PHS II trial included Lawrence Cohen, Rory Collins, Theodore Colton, I. Craig Henderson, Andrea LaCroix, Ross Prentice, and Nanette Wenger (chair); ex-officio members included Mary Francis Cotch, Jeffrey Cutler, Frederick Ferris, Jerome Fleg, Peter Greenwald, Natalie Kurinij, Howard Parnes, Marjorie Perloff, Eleanor Schron, and Alan Zonderman.
Disclaimer: Dr Gaziano, a contributing editor for JAMA, was not involved in the editorial review of or decision to publish this article.
Additional Contributions: We thank the 14 641 physician participants for their long-standing dedication and conscientious collaboration. We also thank Charles Hennekens, MD, DrPH (Florida Atlantic University), for the long-term contributions to the PHS, and the exemplary contributions of the staff of the PHS at Brigham and Women's Hospital, under the leadership of Joanne Smith: Charlene Belanger, Eileen Bowes, Kenneth Breen, Mary Breen, Mary G. Breen, Jose Carrion, Shamikhah Curry, Colleen Evans, Ivan Fitchorov, Natalya Gomelskaya, Cindy Guo, Delia Guo, Jasmah Hanna, Beth Holman, Andrea Hrbek, Gregory Kotler, Tony Laurinaitis, Hannah Mandel, Chandra McCarthy, Geneva McNair, Annie Murray, Leslie Power, Philomena Quinn, Harriet Samuelson, Fred Schwerin, Andromache Sheehey, Sara Tower, Martin Van Denburgh, Diana Walrond, Phyllis Johnson Wojciechowski, and Angela Zhang. In addition, we thank the PHS Endpoints Committee, including Samuel Goldhaber, Carlos Kase, Meir Stampfer, and James Taylor, over the course of PHS II. Each named individual was compensated for his or her contribution as part of the grant support.