Study concept and design: Gutiérrez, Muntner, McClellan, Cushman, Safford.
Acquisition of data: Cushman, Safford.
Analysis and interpretation of data: Gutiérrez, Khodneva, Muntner, Rizk, Warnock, Safford.
Drafting of the manuscript: Gutiérrez, Khodneva, Safford.
Critical revision of the manuscript for important intellectual content: Muntner, Rizk, McClellan, Cushman, Warnock, Safford.
Statistical analysis: Khodneva, Safford.
Obtained funding: Cushman, Warnock, Safford.
Administrative, technical, or material support: Cushman, Safford.
Study supervision: Gutiérrez, Muntner, Cushman, Safford.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Gutiérrez and Warnock report receipt of research support from Amgen. Dr Muntner reports receipt of a grant to the institution and consultancy fees from Amgen. Dr Rizk reports receipt of consultancy fees from Amgen and receipt of a grant to the institution from Amgen for the EVOLVE trial and from REATA Pharmaceuticals for the BEACON trial and the Bardoxilone pharmacokinetic studies. Dr McClellan reports board membership with Arbor Research. Dr Cushman reports receipt of a grant to the institution (through a project subcontract from the University of Alabama at Birmingham to the University of Vermont, Burlington) from Amgen. Dr Warnock reports being a member of the Amgen National Nephrology Advisory Board, receipt of honoraria from Amgen and Sanofi-Genzyme for consultancy services, and stock or stock options with REATA. Dr Safford reports receipt of consultancy fees from diaDexus. Dr Khodneva reports no financial disclosures.
Funding/Support: This study was supported by a cooperative agreement from the National Institute of Neurological Disorders and Stroke (NINDS, U01 NS041588) and from the National Heart, Lung, and Blood Institute (NHLBI, R01 HL080477). Dr Gutiérrez was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK, K23DK081673 and R03DK095005) and from NINDS (R01NS080850). Additional funding was provided by an investigator-initiated grant-in-aid from Amgen.
Role of the Sponsor: The manuscript was sent to Amgen for review prior to submission for publication. Amgen representatives were involved in the review of the manuscript. Amgen did not have any role in the design and conduct of the study, the collection, management, data analysis, or interpretation of the data, the preparation of the manuscript, or the decision to submit the manuscript.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of NIDDK, NINDS, NHLBI, or the National Institutes of Health.
Additional Contributions: We thank the other investigators, the staff, and the participants of the REGARDS study for their valuable contributions. A full list of participating REGARDS investigators and institutions can be found at http://www.regardsstudy.org. We also thank Joshua S. Richman, MD, PhD, University of Alabama at Birmingham, for his assistance with the analyses. Dr Richman did not receive compensation in association with his contribution to this article.