Published Online: May 5, 2013. doi:10.1001/jama.2013.4997
Author Contributions: Drs Chew and Clemons 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: Chew, Clemons, SanGiovanni, Danis, Ferris, Sperduto.
Acquisition of data: Danis, Elman, Antoszyk, Ruby, Orth, Bressler, Fish, Hubbard, Klein, Chandra, Blodi, Domalpally, Friberg, Wong, Rosenfeld, Toth, Bernstein.
Analysis and interpretation of data: Chew, Clemons, SanGiovanni, Danis, Ferris, Elman, Antoszyk, Orth, Fish, Klein, Domalpally, Wong, Rosenfeld, Agron, Toth, Bernstein, Sperduto.
Drafting of the manuscript: Chew, Clemons, Danis, Friberg, Agron.
Critical revision of the manuscript for important intellectual content: Chew, Clemons, SanGiovanni, Danis, Ferris, Elman, Antoszyk, Ruby, Orth, Bressler, Fish, Hubbard, Klein, Chandra, Blodi, Domalpally, Friberg, Wong, Rosenfeld, Agron, Toth, Bernstein, Sperduto.
Statistical analysis: Clemons, Ferris, Agron.
Obtained funding: Chew, Danis, Ferris.
Administrative, technical, or material support: Chew, Danis, Ferris, Elman, Ruby, Bressler, Chandra, Domalpally, Wong, Rosenfeld, Sperduto.
Study supervision: Chew, Clemons, Danis, Ferris, Bressler, Domalpally, Friberg.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ferris reported holding a patent for the Age-Related Eye Disease Study (AREDS) formulation with Bausch & Lomb. Dr Antoszyk reported receiving grant and travel support from Southwest Clinical Research Associates LLC. Dr Ruby reported receiving payment for lectures from Genentech. Dr Bressler reported receiving grant and travel support from the Emmes Corporation; serving as a consultant for GlaxoSmithKline; receiving grants or grants pending from Allergan, Bayer Healthcare, Genentech, Lumenis Inc, Notal Vision Ltd, Novartis, Regeneron, Thrombogenics, and sanofi-aventis; receiving payment for lectures from providers of continuing medical education materials; and serving as an investigator on a grant to The Johns Hopkins University sponsored by Bausch & Lomb; this grant is negotiated and administered by the School of Medicine, which receives the grant through the Office of Research Administration (individual investigators who participate in such sponsored projects are not directly compensated by the sponsor but may receive salary or other support from the institution to support their effort on the projects). Dr Fish reported receiving grant and travel support from Texas Retina Associates. Dr Rosenfeld reported serving as a consultant for Oraya, Novartis, Chengdu Kanghong Biotech, Acucela, Thrombogenics, and Canon; receiving grants or grants pending from Carl Zeiss Meditec, Alexion, Potentia, and GlaxoSmithKline; and receiving payment for lectures from Carl Zeiss Meditec, Allergan, and Topcon. Dr Toth reported receiving grant and travel support from the Emmes Corporation and serving as a consultant to ALCON. Dr Bernstein reported serving as a consultant for Kemin Health, Kalsec, DSM, and Science Based Health. No other authors reported disclosures.
Funding/Support: This study was supported by the intramural program funds and contracts from the National Eye Institute (NEI), National Institutes of Health (NIH), Department of Health and Human Services, Bethesda, Maryland (contract HHS-N-260-2005-00007-C; ADB contract N01-EY-5-0007). Funds were generously contributed to these contracts by the following NIH institutes: Office of Dietary Supplements; National Center for Complementary and Alternative Medicine; National Institute on Aging; National Heart, Lung, and Blood Institute; and National Institute of Neurological Disorders and Stroke. The study medications and raw materials were provided by Alcon, Bausch & Lomb, DSM, and Pfizer.
Role of the Sponsor: The staff of the National Eye Institute and their contractors, led by Dr Chew, had complete control of the design and conduct of the study; the collection, management, analysis, and interpretation of the data; and the preparation, review, or approval of the manuscript. The contributing institutes from the NIH were consulted for various aspects of the study, including its design and conduct. The analyses were completed at the NEI/NIH. The sponsors who donated the study medications had no role in the design or conduct of the study and had no access to the data during the study.
Online-Only Material: The Author Video Interview is available .
This article was corrected for errors on May 14, 2013.