Published Online: August 11, 2014. doi:10.1001/jamainternmed.2014.3463.
Study concept and design: All authors.
Acquisition, analysis, or interpretation of data: Schröder, Salas-Salvadó, Martínez-González, Fíto, Corella, Estruch.
Drafting of the manuscript: Schröder, Martínez-González, Fíto.
Critical revision of the manuscript for important intellectual content: Salas-Salvadó, Martínez-González, Fíto, Corella, Estruch, Ros.
Statistical analysis: Schröder, Martínez-González.
Obtained funding: Salas-Salvadó, Martínez-González, Corella, Estruch, Ros.
Administrative, technical, or material support: Salas-Salvadó, Martínez-González, Fíto, Corella, Estruch.
Study supervision: Schröder, Salas-Salvadó, Martínez-González, Corella, Estruch.
Conflict of Interest Disclosures: Dr Salas-Salvadó serves on the board of and receives grant support through his institution from the International Nut and Dried Fruit Council, receives consulting fees from Danone, and receives grant support through his institution from Eroski and Nestlé. Dr Estruch serves on the board of and receives lecture fees from the Research Foundation on Wine and Nutrition, serves on the boards of the Beer and Health Foundation and the European Foundation for Alcohol Research, receives lecture fees from Cerveceros de España and sanofi-aventis, and receives grant support through his institution from Novartis. Dr Ros serves on the board of and receives travel support, as well as grant support through his institution, from the California Walnut Commission; serves on the board of the Flora Foundation (Unilever); serves on the board of and receives lecture fees from Roche; serves on the board of and receives grant support through his institution from Amgen; receives consulting fees from Damm and Abbott Laboratories; receives consulting fees and lecture fees, as well as grant support through his institution, from Merck; receives lecture fees from Aegerion, AstraZeneca, Danone, Pace, and Rottapharm; receives lecture fees and payment for the development of educational presentations, as well as grant support through his institution, from Ferrer; receives payment for the development of educational presentations from Recordati; and receives grant support through his institution from Daiichi Sankyo, Feiraco, Karo Bio, Nutrexpa, Pfizer, sanofi-aventis, Synageva, Takeda, and Unilever.
Funding/Support: The PREDIMED trial was supported by the official funding agency for Biomedical Research of the Spanish Government, Instituto de Salud Carlos III, through grants provided to research networks specifically developed for the trial: RTIC G03/140 (coordinator: R. Estruch, MD, PhD), CIBERobn (coordinator: F. Casanueva, MD, PhD), and RTIC RD 06/0045 (coordinator: M.A. Martínez-González, MD, PhD). We also acknowledge grants from Centro Nacional de Investigaciones Cardiovasculares CNIC 06/2007, Fondo de Investigación Sanitaria–Fondo Europeo de Desarrollo Regional (PI04-2239, PI 05/2584, CP06/00100, PI07/0240, PI07/1138, PI07/0954, PI 07/0473, PI10/01407, PI11/01647), Ministerio de Ciencia e Innovación (AGL-2009-13906-C02, AGL2010-22319-C03), Fundación Mapfre 2010, Public Health Division of the Department of Health of the Autonomous Government of Catalonia and Generalitat Valenciana (ACOMP06109, GVACOMP2010-181, GVACOMP2011-151, CS2010-AP-111, and CS2011-AP-042), and a joint contract (CES09/030) with the Instituto de Salud Carlos III and the Health Department of the Catalan Government (Generalitat de Catalunya).
Role of the Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Trial Registration: isrctn.org Identifier: ISRCTN35739639
Additional Information: The supplemental foods used in PREDIMED study were generously donated by Patrimonio Comunal Olivarero and Hojiblanca from Spain (extra-virgin olive oil), the California Walnut Commission from Sacramento, CA (walnuts), and Borges S.A. (almonds) and La Morella Nuts (hazelnuts), both from Reus, Spain. CIBERobn and RTIC RD 06/0045 are initiatives of Instituto de Salud Carlos III, Spain.