Author Contributions: Dr Lee 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: Lee, Cook, Gaziano,
Gordon, Ridker, Manson, Hennekens, Buring.
Acquisition of data: Lee, Gaziano, Gordon,
Analysis and interpretation of data: Lee, Cook,
Gaziano, Ridker, Manson, Hennekens, Buring.
Drafting of the manuscript: Lee.
Critical revision of the manuscript for important
intellectual content: Lee, Cook, Gaziano, Gordon, Ridker, Manson, Hennekens,
Statistical analysis: Cook.
Obtained funding: Hennekens, Buring.
Administrative, technical, or material support:
Lee, Gaziano, Gordon, Ridker, Manson, Hennekens, Buring.
Study supervision: Lee, Gaziano, Gordon, Ridker,
Manson, Hennekens, Buring.
Financial Disclosures: Dr Cook has served as
a consultant to Bayer. Dr Gaziano has served as a consultant to and received
grant support from Bayer, DSM Nutritional Products Inc, and McNeil. Dr Ridker
has received grant support from Bayer. Dr Hennekens has served as a consultant
to Bayer and McNeil and received grant support from Bayer.
Funding/Support: This study was supported by
grants HL-43851 and CA-47988 from the National Heart, Lung, and Blood Institute
and the National Cancer Institute. Vitamin E and vitamin E placebo were provided
by the Natural Source Vitamin E Association. Aspirin and aspirin placebo (reported
on pp 47-55) were provided by Bayer Healthcare.
Role of the Sponsor: Neither the Natural Source
Vitamin E Association nor Bayer Healthcare provided any input into the design
and conduct of the study; collection, management, analysis, and interpretation
of the data; or preparation, review, or approval of the manuscript.
Data and Safety Monitoring Board: Lawrence
Cohen, Rory Collins, Theodore Colton, David DeMets, I. Craig Henderson, Andrea
La Croix, Ross Prentice, and Nanette Wenger (chair) and Mary Frances Cotch,
Frederick Ferris, Lawrence Friedman, Peter Greenwald, Natalie Kurinij, Marjorie
Perloff, Eleanor Schron, and Alan Zonderman (ex-officio members).
Acknowledgment: We are indebted to the 39 876
participants in the Women’s Health Study for their dedicated and conscientious
collaboration; to the entire staff of the Women’s Health Study, under
the leadership of David Gordon, Maria Andrade, Susan Burt, Mary Breen, Marilyn
Chown, Lisa Fields-Johnson, Georgina Friedenberg, Inge Judge, Jean MacFadyen,
Geneva McNair, Laura Pestana, Philomena Quinn, Claire Ridge, Harriet Samuelson,
Fred Schwerin and Marty Van Denburgh; to Christine Albert, Michelle Albert,
Gavin Blake, Claudia Chae, Wendy Chen, Richard Doll, Carlos Kase, Tobias Kurth,
Richard Peto, Aruna Pradhan, Kathryn Rexrode, Bernard Rosner, Jacqueline Suk,
and Shumin Zhang for their assistance in the design and conduct of the trial;
and especially to James Taylor for chairing the Endpoints Committee.