Author Contributions: Dr Brouwer 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: Brouwer, Zock, Camm, Böcker, Hauer, Wever, Ronden, Katan, Schouten.
Acquisition of data: Brouwer, Zock, Böcker, Hauer, Wever, Dullemeijer, Ronden, Lubinski, Buschler, Schouten.
Analysis and interpretation of data: Brouwer, Zock, Camm, Dullemeijer, Katan, Lubinski, Schouten.
Drafting of the manuscript: Brouwer, Zock, Camm, Hauer, Schouten.
Critical revision of the manuscript for important intellectual content: Brouwer, Zock, Camm, Böcker, Hauer, Wever, Dullemeijer, Ronden, Katan, Lubinski, Buschler.
Statistical analysis: Brouwer, Zock, Dullemeijer, Schouten.
Obtained funding: Brouwer, Zock, Katan, Schouten.
Administrative, technical, or material support: Brouwer, Böcker, Hauer, Dullemeijer, Ronden, Buschler.
Study supervision: Brouwer, Zock, Camm, Böcker, Hauer, Katan, Schouten.
Financial Disclosures: None reported.
Funding/Support: Funding for this study was provided by Wageningen Centre for Food Sciences, a non-profit alliance of major Dutch food industries, TNO Nutrition and Food Research, Maastricht University and Wageningen University and Research Centre, the Netherlands, with financial support by the Dutch government. An additional grant was received from the European Union (SEAFOODplus integrated project: No. 506359).
Role of the Sponsor: The SOFA trial was designed by the members of the executive and steering committees and then approved by the member organizations of the funder, Wageningen Centre for Food Sciences (WCFS). No industry members of WCFS were involved in the conduct of the study; in the collection, management, analysis, and intrepretation of the data; or in the preparation, review, and approval of the manuscript. Dr Peter Zock left Wageningen University on February 1, 2005, to join Unilever, which is a member organization of the trial's funder WCFS. Since February 2005 he has contributed to writing the manuscript. However, this was not in his capacity as a Unilever employee, and Dr Zock's contributions to the manuscript since February 2005 were neither submitted to, nor seen, revised, or approved by his employer, Unilever.
The SOFA Study Group:Executive Committee/Data analyses: I. A. Brouwer, C. Dullemeijer; Steering Committee: E. G. Schouten (chair), A.J. Camm (co-chair), P. L. Zock, D. Böcker, R. N. W. Hauer, E. F. D. Wever, J. E. Ronden; Investigators: A. Zienciuk, A. Lubinski (Medical University of Gdansk, Gdansk, Poland), J. Vogt, H. Buschler (Herz-und Diabeteszentrum Bad Oeynhausen, Bad Oeynhausen, Germany), J. Köbe, D. Böcker (Universitätsklinikum Münster, Münster, Germany), Z. Kornacewicz-Jach, R. Rzeuski (Pomeranian Academy of Medicine, Szczecin, Poland), A.R. Ramdat Misier (Isala Clinics, Zwolle, the Netherlands), E. F. D. Wever (St. Antonius Hospital, Nieuwegein, the Netherlands), H. Szwed, A. Przybylski (Instytut Kardiologii, Warzawa, Poland), R. N. W. Hauer (UMC Utrecht, Utrecht, the Netherlands), M. Sepsi, B. Semrad (FN Brno Interni Kardiologicka Klinika, Brno, the Czech Republic), A. Meijer (Catharina Hospital, Eindhoven, the Netherlands), L. J. Jordaens (Erasmus Medical Centre Rotterdam, Rotterdam, the Netherlands), A. J. Camm, I. Savelieva (St George's Hospital, London, England), R. Tavernier (University Hospital Gent, Gent, Belgium), H. R. Figulla, C. Kalmbach (Klinikum der Friedrich-Schiller-Universität, Jena, Germany), A. A. M. Wilde (Academic Medical Centre, Amsterdam, the Netherlands), M. Trusz-Gluza, A. Filipecki (I Klinika Kardiologii, Katowice, Poland), W. Haverkamp (Medizinische Klinik m. S. Kardiologie, Berlin, Germany), M. Zabel (Klinikum Benjamin Franklin Berlin, Berlin, Germany), J. M. Morgan (Southampton General Hospital, Southampton, England), H. Pitschner (Kerckhoff-Klinik GmbH, Bad Nauheim, Germany), M. J. Griffith (Queen Elizabeth Hospital, Birmingham, England), A. Podczeck, K. Steinbach (Wilhelminenspital Wien, Vienna, Austria), M. Block (Stiftsklinik Augustinum, Munchen, Germany), P. Kulakowski (Grochowski Hospital, Warszawa, Poland), J. Kautzner (Institute of Clinical and Experimental Medicine, Prague, the Czech Republic), M. Fromer (CHUV, University Hospital Lausanne, Lausanne, Switzerland).
Core Laboratory: D. A. M. J. Theuns (Cardialysis, Rotterdam, the Netherlands).
Endpoint Adjudication Committee Members: I. Savelieva, C. Wolpert (University Hospital Mannheim, Mannheim, Germany), A. A. M. Wilde, J. O. Schwab (Universitätsklinikum Bonn, Bonn, Germany), M. Fromer, M. J. Griffith, L. J. Jordaens (Erasmus University Rotterdam, Rotterdam, the Netherlands).
Data and Safety Monitoring Board Members: E. Boersma (Erasmus Medical Centre Rotterdam, Rotterdam, the Netherlands), P. J. Schwartz (University of Pavia, Pavia, Italy), K. Swedberg (Göteborg University, Göteberg, Sweden).
Acknowledgment: The data analyses were checked by E. Boersma, MSc, PhD, statistician at the Erasmus Medical Centre Rotterdam, Department of Cardiology, the Netherlands. Dr Boersma received compensation for his work as the chair of the data and safety monitoring board, but did not receive any compensation for checking the data analyses. We thank all the research nurses, co-investigators, research assistants at Wageningen University, the personnel of the Core Laboratory in Rotterdam and the Laboratory of the Division of Human Nutrition in Wageningen for their valuable contributions to the study.