Author Contributions: Dr Ockene 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: Ockene, Barad, Cochrane,
Larson, Gass, Wassertheil-Smoller, Manson, Barnabei, Lane, Rosal, Wylie-Rosett,
Acquisition of data: Ockene, Barad, Gass, Wassertheil-Smoller,
Manson, Lane, Brzyski.
Analysis and interpretation of data: Ockene,
Barad, Cochrane, Larson, Gass, Wassertheil-Smoller, Manson, Barnabei, Lane,
Brzyski, Rosal, Hays.
Drafting of the manuscript: Ockene, Barad,
Cochrane, Larson, Barnabei, Lane.
Critical revision of the manuscript for important
intellectual content: Ockene, Barad, Cochrane, Larson, Gass, Wassertheil-Smoller,
Manson, Barnabei, Lane, Brzyski, Rosal, Wylie-Rosett, Hays.
Statistical analysis: Barad, Larson, Wassertheil-Smoller.
Obtained funding: Ockene, Wassertheil-Smoller,
Manson, Lane, Brzyski, Hays.
Administrative, technical, or material support:
Ockene, Cochrane, Manson, Lane, Brzyski, Hays.
Study supervision: Ockene, Gass, Wassertheil-Smoller,
Manson, Barnabei, Lane, Brzyski, Hays.
Financial Disclosures: Dr Gass has received
research grants and contracts from Eli Lilly & Co, GlaxoSmithKline, Merck
& Co, Pfizer Inc, Procter & Gamble Pharmaceuticals, and Wyeth-Ayerst
Laboratories; has received honoraria or consultation fees from Aventis, GlaxoSmithKline,
Merck & Co, and Procter & Gamble Pharmaceuticals; and has served on
advisory boards for Eli Lilly & Co, Merck & Co, Procter & Gamble
Pharmaceuticals, and Solvay Pharmaceuticals. No other authors reported disclosures.
WHI Program Office: National Heart, Lung, and
Blood Institute, Bethesda, Md (Barbara Alving, Jacques Rossouw, Linda Pottern).
Clinical Coordinating Centers: Fred Hutchinson
Cancer Research Center, Seattle, Wash (Ross Prentice, Garnet Anderson, Andrea
LaCroix, Ruth E. Patterson, Anne McTiernan); Wake Forest University School
of Medicine, Winston-Salem, NC (Sally Shumaker, Pentti Rautaharju); Medical
Research Labs, Highland Heights, Ky (Evan Stein); University of California,
San Francisco (Steven Cummings); University of Minnesota, Minneapolis (John
Himes); University of Washington, Seattle (Bruce Psaty).
Clinical Centers: Albert Einstein College of
Medicine, Bronx, NY (Sylvia Wassertheil-Smoller); Baylor College of Medicine,
Houston, Tex (Jennifer Hays); Brigham and Women's Hospital, Harvard Medical
School, Boston, Mass (JoAnn Manson); Brown University, Providence, RI (Annlouise
R. Assaf); Emory University, Atlanta, Ga (Lawrence Phillips); Fred Hutchinson
Cancer Research Center, Seattle, Wash (Shirley Beresford); George Washington
University Medical Center, Washington, DC (Judith Hsia); Harbor-UCLA Research
and Education Institute, Torrance, Calif (Rowan Chlebowski); Kaiser Permanente
Center for Health Research, Portland, Ore (Evelyn Whitlock); Kaiser Permanente
Division of Research, Oakland, Calif (Bette Caan); Medical College of Wisconsin,
Milwaukee (Jane Morley Kotchen); MedStar Research Institute/Howard University,
Washington, DC (Barbara V. Howard); Northwestern University, Chicago/Evanston,
Ill (Linda Van Horn); Rush-Presbyterian St Luke's Medical Center, Chicago,
Ill (Henry Black); Stanford Prevention Research Center, Stanford, Calif (Marcia
L. Stefanick); State University of New York, Stony Brook (Dorothy Lane); Ohio
State University, Columbus (Rebecca Jackson); University of Alabama, Birmingham
(Cora Beth Lewis); University of Arizona, Tucson/Phoenix (Tamsen Bassford);
University of New York, Buffalo (Jean Wactawski-Wende); University of California
at Davis, Sacramento (John Robbins); University of California at Irvine, Orange
(Allan Hubbell); University of California, Los Angeles (Howard Judd); University
of California at San Diego, LaJolla/Chula Vista (Robert D. Langer); University
of Cincinnati, Cincinnati, Ohio (Margery Gass); University of Florida, Gainesville/Jacksonville
(Marian Limacher); University of Hawaii, Honolulu (David Curb); University
of Iowa, Iowa City/Davenport (Robert Wallace); University of Massachusetts/Fallon
Clinic, Worcester (Judith Ockene); University of Medicine and Dentistry of
New Jersey, Newark (Norman Lasser); University of Miami, Miami, Fla (Mary
Jo O’Sullivan); University of Minnesota, Minneapolis (Karen Margolis);
University of Nevada, Reno (Robert Brunner); University of North Carolina,
Chapel Hill (Gerardo Heiss); University of Pittsburgh, Pittsburgh, Pa (Lewis
Kuller); University of Tennessee, Memphis (Karen C. Johnson); University of
Texas Health Science Center, San Antonio (Robert Brzyski); University of Wisconsin,
Madison (Gloria Sarto); Wake Forest University School of Medicine, Winston-Salem,
NC (Denise Bonds); Wayne State University School of Medicine/Hutzel Hospital,
Detroit, Mich (Susan Hendrix).
Funding/Support: The National Heart, Lung,
and Blood Institute funds the Women’s Health Initiative program. Wyeth-Ayerst
provided the study pills (active and placebo).
Role of the Sponsor: The National Heart, Lung,
and Blood Institute participated in the design, conduct, and oversight of
the trial and reviewed and approved the analysis plan for this manuscript
and the completed manuscript. Wyeth-Ayerst provided study pills only and had
no involvement in the design or conduct of the trial.