Author Contributions: Drs Cole and Baron 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 analysis.
Study concept and design: Cole, Baron, Sandler, Ahnen, Bresalier, Burke, Snover, Allen, Beck, Bond, Byers, Mandel, Pearson, Greenberg.
Acquisition of data: Baron, Sandler, Haile, Ahnen, Bresalier, McKeown-Eyssen, Summers, Rothstein, Burke, Snover, Church, Allen, Beck, Bond, Byers, Mandel, Barry, Rees, Marcon, Saibil, Ueland.
Analysis and interpretation of data: Cole, Baron, Sandler, Haile, Ahnen, Bresalier, McKeown-Eyssen, Church, Allen, Robertson, Beck, Byers, Mott, Greenberg.
Drafting of the manuscript: Cole, Baron, Allen, Byers, Mott, Saibil, Greenberg.
Critical revision of the manuscript for important intellectual content: Baron, Sandler, Haile, Ahnen, Bresalier, McKeown-Eyssen, Summers, Rothstein, Burke, Snover, Church, Allen, Robertson, Beck, Bond, Byers, Mandel, Pearson, Barry, Rees, Marcon, Ueland, Greenberg.
Statistical analysis: Cole, Baron, Haile, Church, Byers, Mott, Greenberg.
Obtained funding: Cole, Baron, Ahnen, Bresalier, Church, Byers, Mandel.
Administrative, technical, or material support: Cole, Baron, Sandler, Bresalier, McKeown-Eyssen, Rothstein, Burke, Snover, Church, Beck, Bond, Mandel, Pearson, Barry, Saibil.
Study supervision: Cole, Baron, Haile, Bresalier, Summers, Church, Allen, Beck, Mandel, Marcon.
Financial Disclosures: Dr Cole reported being a consultant to Schering-Plough. Dr Baron reported being a consultant to Merck and Bayer. Dartmouth College and Dr Baron hold a use patent for calcium supplementation, which is licensed to Wyeth Consumer Health Care. Dr Sandler reported receiving research support from Merck and being a consultant to Merck, Bayer, GlaxoSmithKline, and Procter & Gamble. Ms Mott reported that she has equity interest in Wyeth. No other authors reported any financial disclosures.
Polyp Prevention Study Group Investigators, Study Coordinators, and Coordinating Center Staff (listed alphabetically within study site):Cleveland Clinic Foundation, Cleveland, Ohio: J. Bauman, H. Hasson; University of Colorado Health Sciences Center, Denver: L. Richman, R. Reveille, R. Roller (Rocky Mountain Gastroenterology Associates, Lakewood, Colo), J. Levine (University of Colorado Hospital, Denver), P. Baker, P. Hanna, D. Hruza (South Denver Endoscopy, Denver, Colo), A. Triebling (Arapahoe Gastroenterology, Littleton, Colo), S. Lawrence, V. Jakribettuu (Denver Veterans Affairs Medical Center, Denver, Colo), S. Frederick, S. Rein; Dartmouth-Hitchcock Medical Center, Lebanon, NH: D. Howell (Portland Gastroenterology Associates, Portland, Me), P. Moses (University of Vermont College of Medicine, Burlington), A. Robinson (Claremont, NH), A. Warner (Lahey Clinic, Burlington, Mass), D. Chamberlain, M. Hynes, L. Wetteman; Henry Ford Health Sciences Center, Detroit, Mich: B. Zonka; University of Iowa College of Medicine, Iowa City: D. Abramson, D. Purdy, R. Silber, G. Weinman (Gastroenterologists, P.C.I., Cedar Rapids, Iowa), N. Dusdieker (Internists, P.C., Cedar Rapids, Iowa), J. Ewing, B. O’Meara (Gastroenterology Associates of Iowa City, Iowa City, Iowa), R. Thompson; University of Minnesota, Minneapolis: the physicians of Minnesota Gastroenterology P.A., J. Blomquist; University of North Carolina School of Medicine, Chapel Hill: S. Levinson (Chapel Hill Internal Medicine, Chapel Hill, NC), R. McCall, M. Pate (Mid-Carolina Gastroenterology, Sanford, NC), R. Schwarz (Raleigh Medical Group, Raleigh, NC), R. Buccini (Eagle Gastroenterology, Greensboro, NC), J. Weissman (Tannenbaum Associates, Greensboro, NC), B. Schliebe; University of Southern California, Los Angeles: B. Batra, D. Berkowitz, E. Lever (Kaiser-Bellflower, Bellflower, Calif), C. Conteas, T. Teller (Kaiser-Sunset, Los Angeles, Calif), L. Gerstmann, P. Harmon, A. Montes, N. Uk.; University of Toronto, Toronto, Ontario: E. Irvine (McMaster University Hamilton Health Sciences Centre, Hamilton, Ontario), L. Cohen, M. Cooper, T. Devlin, D. Hemphill, E. Hurowitz, H. Price, S. Stafford (Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario), N. Bassett, V. Jazmaji, M. Morgan, L. Vernich; Dartmouth Medical School, Hanover, NH: B. Beaulieu, D. Carmichael, P. Courtney, J. Dykes, S. Ewell, J. Hebb, S. Raymond, S. Rovell-Rixx, B. Thomas.
Data and Safety Monitoring Committee: F. Giardiello (Johns Hopkins University School of Medicine, Baltimore, Md), J. Lachin (George Washington University, Washington, DC), J. Neaton (University of Minnesota, Minneapolis), L.J. Roberts (Vanderbilt University School of Medicine, Nashville, Tenn), W. Willett (chairman; Harvard University, Boston, Mass).
Funding/Support: This work was supported in part by grants 5 R01 CA059005 and U54 CA100971 from the National Institutes of Health. Study tablets were provided by Wyeth Consumer Health Care, Madison, NJ.
Role of the Sponsor: The funding organizations played no role in the 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.
Acknowledgment: We thank all the individuals who participated in this clinical trial.