Accepted for Publication: September 30, 2013.
Published Online: November 5, 2013. doi:10.1001/jamainternmed.2013.12505.
Study concept and design: McCombs, Tonnu-Mihara, Saab, Hines, L’Italien, Yuan.
Acquisition of data: Tonnu-Mihara.
Analysis and interpretation of data: McCombs, Matsuda, Tonnu-Mihara, Saab, L’Italien, Juday, Yuan.
Drafting of the manuscript: McCombs, Matsuda, Saab, L’Italien.
Critical revision of the manuscript for important intellectual content: McCombs, Tonnu-Mihara, Saab, Hines, L’Italien, Juday, Yuan.
Statistical analysis: McCombs, Matsuda, Tonnu-Mihara, Hines, L’Italien, Yuan.
Obtained funding: McCombs, Yuan.
Administrative, technical, or material support: McCombs, Tonnu-Mihara, Juday, Yuan.
Study supervision: McCombs, Tonnu-Mihara, Saab.
Conflict of Interest Disclosures: Dr McCombs received salary and travel support under the terms of the research grant between Bristol-Myers Squibb and the University of Southern California. Ms Matsuda was supported as a University of Southern California graduate research assistant under the terms of the grant. Dr Tonnu-Mihara is employed by the US Department of Veterans Affairs (VA). Dr Saab maintains a consultancy with Bristol-Myers Squibb. Ms Hines and Drs L’Italien, Juday, and Yuan are employees of Bristol-Myers Squibb. The study did not involve specific drugs or drugs marketed by the sponsor. No other conflicts were reported.
Funding/Support: Financial support for this research was provided by Bristol-Myers Squibb. The University subcontracted with the VA for access to the data.
Role of the Sponsor: The University of Southern California maintained all rights to publication subject to a time-limited period for review and comment by Bristol-Myers Squibb. In addition, those coauthors of this study who are also employees of Bristol-Myers Squibb (Ms Hines and Drs L’Italien, Juday, and Yuan) were fully involved with all aspects of this research.
Previous Presentation: The manuscript for this article was accepted as a podium presentation at the Liver Meeting; November 5, 2013; Washington, DC.
Additional Contributions: The authors acknowledge Anupama Kalsekar, PhD, from Bristol-Myers Squibb for her scientific critique and Tim Morgan, MD, from the Long Beach VA center for his support of the project. Neither acknowledged person was compensated for the work on this article.
Additional Information: Dr McCombs is an experienced investigator and well trained in the multivariate statistical techniques used in this analysis. Dr McCombs served as the independent statistical analyst for the research.