Author Contributions: Dr Chlebowski 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: Chlebowski, Manson, Wactawski-Wende, Hendrix, Prentice.
Acquisition of data: Chlebowski, Gass, Lane, Kuller, Manson, Stefanick, Ockene, Sarto, Johnson, Wactawski-Wende, Hendrix, Yasmeen.
Analysis and interpretation of data: Chlebowski, Anderson, Aragaki, Manson, Johnson, Wactawski-Wende, Ravdin, Schenken, Hendrix, Rajkovic, Rohan, Prentice.
Drafting of the manuscript: Chlebowski, Aragaki, Prentice.
Critical revision of the manuscript for important intellectual content: Chlebowski, Anderson, Gass, Lane, Aragaki, Kuller, Manson, Stefanick, Ockene, Sarto, Johnson, Wactawski-Wende, Ravdin, Schenken, Hendrix, Rajkovic, Rohan, Prentice.
Statistical analysis: Aragaki, Yasmeen, Prentice.
Obtained funding: Lane, Kuller, Manson, Stefanick, Ockene, Wactawski-Wende, Hendrix, Prentice.
Administrative, technical, or material support: Chlebowski, Anderson, Kuller, Manson, Stefanick, Johnson, Wactawski-Wende, Schenken, Hendrix, Prentice.
Study supervision: Chlebowski, Anderson, Ockene, Johnson, Hendrix, Rajkovic.
Financial Disclosures: Dr Chlebowski reports that he has received consulting fees from AstraZeneca, Novartis, and Pfizer, lecture fees from AstraZeneca and Novartis, and grant funding from Amgen. Dr Gass reports that she has received funding for multisite clinical trials from Procter & Gamble and Wyeth Laboratories and consulting fees from Upsher-Smith Laboratories, Wyeth Pharmaceuticals, and Procter & Gamble. Dr Hendrix reports that she has received consulting fees from Meditrina Pharmaceuticals Inc, lecture fees from Merck, and grant funding from Boehringer Ingelheim and Organon. Dr Rohan reports that he has received consulting fees from legal firms regarding hormone therapy issues. No other financial disclosures were reported.
WHI Investigators: Program Office: National Heart, Lung, and Blood Institute, Bethesda, MD (Elizabeth Nabel, Jacques Rossouw, Shari Ludlam, Joan McGowan, Nancy Geller, Leslie Ford). Clinical Coordinating Center: Fred Hutchinson Cancer Research Center, Seattle, WA (Ross Prentice, Garnet Anderson, Andrea LaCroix, Ruth Patterson, Anne McTiernan, Barbara Cochrane, Julie Hunt, Lesley Tinker, Charles Kooperberg, Martin McIntosh, C. Y. Wang, Chu Chen, Deborah Bowen, Alan Kristal, Janet Stanford, Nicole Urban, Noel Weiss, Emily White); Medical Research Laboratories, Highland Heights, KY (Evan Stein, Peter Laskarzewski); San Francisco Coordinating Center, San Francisco, CA (Steven R. Cummings, Michael Nevitt, Lisa Palermo); University of Minnesota, Minneapolis (Lisa Harnack); Fisher BioServices, Rockville, MD (Frank Cammarata, Steve Lindenfelser); University of Washington, Seattle (Bruce Psaty, Susan Heckbert). Clinical Centers: Albert Einstein College of Medicine, Bronx, NY (Sylvia Wassertheil-Smoller, William Frishman, Judith Wylie-Rosett, David Barad, Ruth Freeman); Baylor College of Medicine, Houston, TX (Aleksandar Rajkovic, Jennifer Hays, Ronald Young, Haleh Sangi-Haghpeykar); Brigham and Women's Hospital, Harvard Medical School, Boston, MA (JoAnn E. Manson, Kathryn M. Rexrode, Brian Walsh, J. Michael Gaziano, Maria Bueche); Brown University, Providence, RI (Charles B. Eaton, Michele Cyr, Gretchen Sloane); Emory University, Atlanta, GA (Lawrence Phillips, Vicki Butler, Vivian Porter); Fred Hutchinson Cancer Research Center, Seattle, WA (Shirley A. A. Beresford, Vicky M. Taylor, Nancy F. Woods, Maureen Henderson, Robyn Andersen); George Washington University, Washington, DC (Lisa Martin, Judith Hsia, Nancy Gaba, Richard Katz); Los Angeles Biomedical Research Institute at Harbor-UCLA Research and Education Institute, Torrance, CA (Rowan Chlebowski, Robert Detrano, Anita Nelson, Michele Geller); Kaiser Permanente Center for Health Research, Portland, OR (Yvonne Michael, Evelyn Whitlock, Victor Stevens, Njeri Karanja); Kaiser Permanente Division of Research, Oakland, CA (Bette Caan, Stephen Sidney, Geri Bailey Jane Hirata); Medical College of Wisconsin, Milwaukee (Jane Morley Kotchen, Vanessa Barnabei, Theodore A. Kotchen, Mary Ann C. Gilligan, Joan Neuner); MedStar Research Institute/Howard University, Washington, DC (Barbara V. Howard, Lucile Adams-Campbell, Lawrence Lessin, Cheryl Iglesia, Linda K Mickel); Northwestern University, Chicago/Evanston, IL (Linda Van Horn, Philip Greenland, Janardan Khandekar, Kiang Liu, Carol Rosenberg); Rush University Medical Center, Chicago, IL (Henry Black, Lynda Powell, Ellen Mason, Martha Gulati); Stanford Prevention Research Center, Stanford, CA (Marcia L. Stefanick, Mark A. Hlatky, Bertha Chen, Randall S. Stafford, Sally Mackey); State University of New York at Stony Brook (Dorothy Lane, Iris Granek, William Lawson, Catherine Messina, Gabriel San Roman); Ohio State University, Columbus (Rebecca Jackson, Randall Harris, Electra Paskett, W. Jerry Mysiw, Michael Blumenfeld); University of Alabama at Birmingham (Cora E. Lewis, Albert Oberman, James M. Shikany, Monika Safford); University of Arizona, Tucson/Phoenix (Cynthia A. Thomson, Tamsen Bassford, Cheryl Ritenbaugh, Zhao Chen, Marcia Ko); University at Buffalo, Buffalo, NY (Jean Wactawski-Wende, Maurizio Trevisan, Ellen Smit, Susan Graham, June Chang); University of California at Davis, Sacramento (John Robbins, S. Yasmeen); University of California at Irvine (F. Allan Hubbell, Gail Frank, Nathan Wong, Nancy Greep, Bradley Monk); University of California at Los Angeles (Lauren Nathan, David Heber, Robert Elashoff, Simin Liu); University of California at San Diego, LaJolla/Chula Vista (Robert D. Langer, Michael H. Criqui, Gregory T. Talavera, Cedric F. Garland, Matthew A. Allison); University of Cincinnati, Cincinnati, OH (Margery Gass, Nelson Watts); University of Florida, Gainesville/Jacksonville (Marian Limacher, Michael Perri, Andrew Kaunitz, R. Stan Williams, Yvonne Brinson); University of Hawaii, Honolulu (J. David Curb, Helen Petrovitch, Beatriz Rodriguez, Kamal Masaki, Patricia Blanchette); University of Iowa, Iowa City/Davenport (Robert Wallace, James Torner, Susan Johnson, Linda Snetselaar, Jennifer Robinson); University of Massachusetts/Fallon Clinic, Worcester (Judith Ockene, Milagros Rosal, Ira Ockene, Robert Yood, Patricia Aronson); University of Medicine and Dentistry of New Jersey, Newark (Norman Lasser, Baljinder Singh, Vera Lasser, John Kostis, Peter McGovern); University of Miami, Miami, FL (Mary Jo O’Sullivan, Linda Parker, JoNell Potter, Diann Fernandez, Pat Caralis); University of Minnesota, Minneapolis (Karen L. Margolis, Richard H. Grimm, Mary F. Perron, Cynthia Bjerk, Sarah Kempainen); University of Nevada, Reno (Robert Brunner, William Graettinger, Vicki Oujevolk, Michael Bloch); University of North Carolina, Chapel Hill (Gerardo Heiss, Pamela Haines, David Ontjes, Carla Sueta, Ellen Wells); University of Pittsburgh, Pittsburgh, PA (Lewis Kuller, Jane Cauley, N. Carole Milas); University of Tennessee Health Science Center, Memphis (Karen C. Johnson, Suzanne Satterfield, Rongling Li, Stephanie Connelly, Fran Tylavsky); University of Texas Health Science Center, San Antonio (Robert Brzyski, Robert Schenken); University of Wisconsin, Madison (Gloria E. Sarto, Douglas Laube, Patrick McBride, Julie Mares, Barbara Loevinger); Wake Forest University School of Medicine, Winston-Salem, NC (Mara Vitolins, Greg Burke, Robin Crouse, Scott Washburn); Wayne State University School of Medicine/Hutzel Hospital, Detroit, MI (Michael Simon). Women's Health Initiative Memory Study: Wake Forest University School of Medicine, Winston-Salem, NC (Sally Shumaker, Stephen Rapp, Claudine Legault, Mark Espeland, Laura Coker). Former Principal Investigators and Project Officers: Baylor College of Medicine, Houston, TX (Jennifer Hays, John Foreyt); Brown University, Providence, RI (Annlouise R. Assaf); Emory University, Atlanta, GA (Dallas Hall); George Washington University, Washington, DC (Valery Miller); Kaiser Permanente Center for Health Research, Portland, OR (Barbara Valanis); Kaiser Permanente Division of Research, Oakland, CA (Robert Hiatt); National Cancer Institute, Bethesda, MD (Carolyn Clifford†); National Heart, Lung, and Blood Institute, Bethesda, MD (Linda Pottern); University of California at Irvine (Frank Meyskens Jr); University of California at Los Angeles (Howard Judd†); University of Cincinnati, Cincinnati, OH (James Liu, Nelson Watts); University of Miami, Miami, FL (Marianna Baum); University of Minnesota, Minneapolis (Richard Grimm); University of Nevada, Reno (Sandra Daugherty†); University of North Carolina, Chapel Hill (David Sheps, Barbara Hulka); University of Tennessee Health Science Center, Memphis (William Applegate); University of Wisconsin, Madison (Catherine Allen†); Wake Forest University School of Medicine, Winston-Salem, NC (Denise Bonds).
Funding/Support: The WHI program is funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, 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: The study sponsor had input into the design and conduct of the study and participated in the report review but did not participate in preparation of the manuscript.
Additional Contributions: We acknowledge the dedicated efforts of the investigators and staff at the WHI clinical centers, the WHI Clinical Coordinating Center, and the National Heart, Lung, and Blood Institute program office (listing available at http://www.whi.org). We recognize the WHI participants for their extraordinary commitment to the WHI program.