Author Contributions: Dr LaCroix 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: Manson, Margolis, Stefanick, Wactawski-Wende.
Acquisition of data: LaCroix, Chlebowski, Manson, Johnson, Margolis, Stefanick, Brzyski, Curb, Howard, Wactawski-Wende.
Analysis and interpretation of data: LaCroix, Chlebowski, Manson, Aragaki, Johnson, Martin, Margolis, Curb, Howard, Lewis, Wactawski-Wende.
Drafting of the manuscript: LaCroix, Manson, Aragaki.
Critical revision of the manuscript for important intellectual content: LaCroix, Chlebowski, Manson, Johnson, Martin, Margolis, Stefanick, Brzyski, Curb, Howard, Lewis, Wactawski-Wende.
Statistical analysis: LaCroix, Aragaki.
Obtained funding: LaCroix, Chlebowski, Manson, Johnson, Stefanick, Curb, Howard, Lewis, Wactawski-Wende.
Administrative, technical, or material support: Chlebowski, Manson, Johnson, Brzyski, Curb, Lewis, Wactawski-Wende.
Study supervision: LaCroix, Johnson, Margolis, Curb, Howard, Wactawski-Wende.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr LaCroix reported serving on scientific advisory committees for research studies funded by Warner Chilcott and sanofi-aventis, Amgen, and Pfizer. Dr Chlebowski reported being a consultant for AstraZeneca, Novartis, Amgen, and Pfizer; receiving funding support from Amgen; and serving on speaker’s bureaus for AstraZeneca and Novartis. Dr Howard reported receiving payment for lectures, serving on a speaker’s bureau, and being a consultant for Merck/Schering-Plough Wyeth Research; and receiving research support through the donation of drugs from Merck/Schering-Plough. None of the other authors reported any financial disclosures.
Funding/Support: Wyeth Ayerst donated the study drugs. The Women's Health Initiative program is funded by the National Heart, Lung, and Blood Institute, the National Institutes of Health, and the US Department of Health and Human Services through contracts N01WH22110, 24152, 32100-2, 32105-6, 32108-9, 32111-13, 32115, 32118-32119, 32122, 42107-26, 42129-32, and 44221.
Role of the Sponsor: Committees of the Women's Health Initiative investigators that included representatives from the National Heart, Lung, and Blood Institute (the study's sponsor) had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation and review of the manuscript. The Women's Health Initiative Project Office at the National Heart, Lung, and Blood Institute approved the manuscript but had no other role.
Women's Health Initiative Investigators: A full listing of Women's Health Initiative investigators can be found at http://whiscience.org/publications/WHI_investigators_longlist_2005-2010.pdf.
Additional Contributions: We thank the Women's Health Initiative investigators and staff for their outstanding dedication and commitment.