Published Online: June 2, 2014. doi:10.1001/jamainternmed.2014.2120.
Study concept and design: Arnold, Kosiborod, Yue, Ben-Yehuda, Spertus.
Acquisition, analysis, or interpretation of data: Arnold, Kosiborod, Li, Yue, Ben-Yehuda, Spertus.
Drafting of the manuscript: Arnold, Ben-Yehuda.
Critical revision of the manuscript for important intellectual content: Arnold, Kosiborod, Li, Yue, Ben-Yehuda, Spertus.
Statistical analysis: Arnold, Li.
Obtained funding: Kosiborod, Yue, Ben-Yehuda.
Administrative, technical, or material support: Yue.
Study supervision: Kosiborod, Ben-Yehuda, Spertus.
Conflict of Interest Disclosures: Dr Arnold received research support from Gilead Sciences, Genentech, and sanofi-aventis. Dr Kosiborod received research support from Gilead Sciences, American Heart Association, Medtronic Minimed, Genentech, sanofi-aventis, Glumetrics, and Maquet; is a consultant for Gilead Sciences, Genentech, F Hoffmann-La Roche, Medtronic Minimed, AstraZeneca, Abbvie, and Regeneron; and served on the advisory board for Gilead Sciences. Dr McGuire is a consultant for Janssen Pharmaceuticals, Daiichi Sankyo, Pfizer, Boehringer-Ingelheim, Regeneron, Genentech, F Hoffmann–La Roche, Merck, Bristol-Myers Squibb, Tethys Biosciences, AstraZeneca, Orexigen, Eli Lilly, and Takeda. Dr Yue is an employee of and owns stock and stock options in Gilead Sciences. Dr Ben-Yehuda is a former employee of Gilead Sciences. Dr Spertus has received research support from Gilead Sciences, National Heart, Lung, and Blood Institute, American College of Cardiology, American Heart Association, Patient-Centered Outcomes Research Institute, Amorcyte, Genentech, and Eli Lilly; is a consultant for Gilead Sciences, Genentech, Amgen, and United Healthcare (Scientific Advisory Group); is a board member for Health Outcomes Sciences; and holds the copyrights for the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire. No other disclosures are reported.
Funding/Support: The TERISA trial was sponsored by Gilead Sciences. Saint Luke’s Mid America Heart Institute received funding for the independent statistical analysis of the TERISA trial from Gilead Sciences.
Role of the Sponsor: As the present study was a planned secondary analysis of the TERISA trial, Gilead Sciences had a role in the design and conduct of the study. The data were collected by Gilead Sciences, who had a role in interpretation of the data and in the preparation and review of the manuscript. An independent statistical analysis of the data was conducted by the study authors. The sponsor had no role in approval of the manuscript and decision to submit the manuscript for publication.
Previous Presentation: This study was presented at the American Heart Association Scientific Sessions; November 19, 2013; Dallas, Texas.
Trial Registration: clinicaltrials.gov Identifier: NCT01425359