Author Contributions: Drs Smith and Pang 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: Smith, Pang, Fleishman, Paskett, Ahles, Bressler, Fadul, Shapiro.
Acquisition of data: Cirrincione, Fleishman, Knox, Le-Lindqwister, Gilman.
Analysis and interpretation of data: Smith, Pang, Cirrincione, Fleishman, Ahles, Fadul.
Drafting of the manuscript: Smith, Pang, Cirrincione, Fleishman, Bressler, Knox.
Critical revision of the manuscript for important intellectual content: Smith, Pang, Cirrincione, Fleishman, Paskett, Ahles, Fadul, Le-Lindqwister, Gilman, Shapiro.
Statistical analysis: Smith, Pang, Cirrincione.
Obtained funding: Smith.
Administrative, technical, or material support: Pang, Fleishman, Paskett, Ahles, Bressler, Knox, Le-Lindqwister, Shapiro.
Study supervision: Smith, Pang, Fleishman, Paskett, Fadul, Gilman.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Smith reported receiving support from CALGB/Alliance for travel to meetings. Dr Paskett reported institutional support from CALGB/Alliance for travel to meetings. Dr Ahles reported receiving support from CALBG/Alliance for travel to meetings. Dr Fadul reported pending institutional grants from Genentech. Dr Gilman reported institutional and direct grants pending from the NCI. No other financial disclosures were made.
Funding/Support: This study was supported by grant CA31946 from the NCI Division of Cancer Prevention, the Alliance Statistics and Data Center, and the Alliance Chairman. Drug and placebo were supplied by Eli Lilly. The NCI provided funding for data management and statistical analysis.
Role of the Sponsor: The NCI and Eli Lilly each reviewed and approved the study concept via the usual peer-review process. Minor suggestions were made by each group regarding aspects of the study design. Neither the NCI Division of Cancer Prevention nor Eli Lilly had a role in data collection or management, analysis, interpretation of the data, or with manuscript preparation, review, or approval.
Online-Only Material: The Author Video Interview is available .
Additional Contributions: We thank the study participants and the research staff at all participating sites. Special thanks are extended to the CALGB Oncology Nursing Committee, Richard Schilsky, MD (American Society of Clinical Oncology), Xiaofei Wang, PhD (Duke University), John Taylor, MA (Alliance), Brandelyn Pitcher, MS (Duke University), Sara Jasinski, BA (Duke University), Celia Bridges, BSN, RN (University of Michigan), and Asa B. Smith, Student (University of Michigan). Dr Wang, Mr Taylor, Ms Pitcher, and Ms Jasinski received salary support from the Alliance Cooperative Group Grant for their contributions to this work. All others provided assistance without receiving financial compensation.