Author Contributions: Dr Najjar 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: Najjar, Rao, Povsic, Melton, Patel, Kim, Talan, Ferrucci, Longo, Lakatta, Harrington.
Acquisition of data: Najjar, Raman, Povsic, Melton, Prather, Heitner, Gruberg, Greenbaum, Patel, Kim, Longo, Harrington.
Analysis and interpretation of data: Najjar, Melloni, Raman, Povsic, Melton, Barsness, Prather, Kilaru, Hasselblad, Kim, Longo, Lakatta, Harrington.
Drafting of the manuscript: Najjar, Prather, Hasselblad, Lakatta.
Critical revision of the manuscript for important intellectual content: Najjar, Rao, Melloni, Raman, Povsic, Melton, Barsness, Prather, Heitner, Kilaru, Gruberg, Greenbaum, Patel, Kim, Talan, Ferrucci, Longo, Lakatta, Harrington.
Statistical analysis: Prather, Kilaru, Hasselblad, Lakatta.
Obtained funding: Najjar, Povsic, Longo, Lakatta, Harrington.
Administrative, technical or material support: Najjar, Rao, Melton, Gruberg, Kim, Longo, Harrington.
Study supervision: Najjar, Rao, Melloni, Raman, Melton, Kim, Longo, Harrington.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Najjar reported receiving research funding from HeartWare. Dr Rao reported receiving research funding from Novartis, Cordis Corporation, and Ikaria; and being a consultant for sanofi-aventis, Bristol-Meyers Squibb, AstraZeneca, Daiichi Sankyo-Lilly, and Terumo USA. Dr Raman reported receiving grant support from the National Institutes of Health and from Siemens Corporation. Dr Povsic reported receiving grants from Baxter International, Regado Biosciences, and Theragen. Dr Barsness reported being a consultant for Gilead Sciences Inc and receiving travel compensation from Novartis Pharmaceuticals Corporation. Dr Heitner reported that New York Methodist Hospital received compensation for his work as a principal investigator for a study; receiving compensation for his expert testimony in an individual malpractice case; receiving grant support from the Empire Clinical Research Investigator Program; and receiving compensation for serving on a steering committee for a trial. Dr Hasselblad reported receiving salary support via grants from Eli Lilly and Medicure Inc administered through Duke University. Dr Greenbaum reported receiving compensation from various law firms for expert testimony; compensation for serving on speakers bureaus for various companies; and owning stock or stock options in various other device and health care companies. Dr Patel reported being a board member for Genzyme's advisory board and Bayer Healthcare; and serving as a consultant for Ikaria. Dr Kim reported being an inventor on a US patent for Delayed Enhancement MRI, which is owned by Northwestern University. Dr Harrington reported that a complete listing of disclosure information is available at https://dcri.org/about-us/conflict-of-interest/Harrington-COI_2010.pdf. None of the other authors reported disclosures.
Funding/Support: This study was supported by Intramural Research Program contract HHS-N-260-2005-00010-C from the National Institute on Aging.
Role of Sponsor: The Duke Clinical Research Institute served as the coordinating center under contract from the National Institute on Aging. Investigators from the National Institute on Aging and the Duke Clinical Research Institute collaborated in designing and supervising the conduct of the study. Neither Centocor Ortho Biotech nor Florida Biologix provided funding or had input into the design or conduct of the study nor any input into data collection, data analysis, or the writing of the manuscript.
REVEAL Data and Safety Monitoring Board: Lawrence J. Appel, MD, MPH (chair), Victor Ferrari, MD, Mark D. Kelemen, MD, MSc, Jon R. Resar, MD, Michael L. Terrin, MD, and Edgar R. Miller III, MD, PhD (secretary).
Previous Presentations: Primary findings were presented at the American Heart Association Annual Meeting; November 17, 2010; Chicago, Illinois.
Additional Contributions: We thank the members of the REVEAL data and safety monitoring board. All of the data and safety monitoring board members received an honorarium for their services from the National Institute on Aging. We also thank Jonathan McCall, BA, of the Duke Clinical Research Institute (Durham, North Carolina), who provided editorial assistance with the manuscript as part of his regular duties as a medical editor. Mr McCall is a salaried employee of the Duke Clinical Research Institute.