Published Online: June 5, 2006 (doi:10.1001/jama.295.23.joc60075).
Author Contributions: Dr Land 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: Wickerham, Costantino, Wolmark, Ganz.
Acquisition of data: Land, Costantino, Ritter, Vogel, Pajon, Wade, Dakhil, Lockhart.
Analysis and interpretation of data: Land, Vogel, Lee, Wolmark, Ganz.
Drafting of the manuscript: Land, Costantino, Vogel, Lee, Wade, Ganz.
Critical revision of the manuscript for important intellectual content: Wickerham, Ritter, Vogel, Pajon, Dakhil, Lockhart, Wolmark, Ganz.
Statistical analysis: Land, Lee.
Obtained funding: Costantino.
Administrative, technical, or material support: Land, Wickerham, Costantino, Ritter, Vogel, Pajon, Wade, Lockhart, Wolmark.
Study supervision: Costantino, Vogel, Pajon, Wolmark, Ganz.
Financial Disclosures: Dr Wickerham has reported serving as a consultant for and on the speaker's bureau of AstraZeneca Pharmaceuticals; Dr Vogel has reported serving on the speaker's bureau of AstraZeneca Pharmaceuticals and Eli Lilly; and Dr Wolmark has reported receiving honorarium from Eli Lilly. No other authors reported disclosures.
Funding/Support: This study was supported by Public Health Service grants U10-CA-37377, U10-CA-69974, U10CA-12027, and U10CA-69651 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, and AstraZeneca Pharmaceuticals and Eli Lilly and Company.
Role of the Sponsor: The study sponsors had no role in any aspect of study design, data collection, analysis and interpretation of data, or in the development of the manuscript. Per contractual arrangement, the manuscript was submitted to AstraZeneca and Eli Lilly before submission.
Acknowledgment: We thank Barbara C. Good, PhD, Director of Scientific Publications for the National Surgical Adjuvant Breast and Bowel Project, and Wendy Rea, BA, for editorial assistance. Dr Good and Ms Rea are employees of the NSABP. They were not compensated beyond their normal salaries for this work. We also thank the courageous participants without whom this trial could not have been accomplished.