Author Contributions: Dr Ebbing 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: Ueland, Nordrehaug, Nilsen, Vollset, Refsum, Nygård.
Acquisition of data: Ebbing, Bleie, Ueland, Ringdal Pedersen, Nygård.
Analysis and interpretation of data: Ebbing, Bleie, Ueland, Nordrehaug, Vollset, Refsum, Nygård.
Drafting the manuscript: Ebbing.
Critical revision of the manuscript for important intellectual content: Ebbing, Bleie, Ueland, Nordrehaug, Nilsen, Vollset, Refsum, Ringdal Pedersen, Nygård.
Statistical analysis: Ebbing, Vollset, Nygård.
Obtained funding: Ueland, Nordrehaug, Nilsen, Vollset, Refsum, Nygård.
Administrative, technical or material support: Bleie, Ueland, Nordrehaug, Nilsen, Vollset, Ringdal Pedersen, Nygård.
Study supervision: Ueland, Nordrehaug, Nilsen, Vollset, Refsum, Nygård.
Financial Disclosures: Dr Ueland reports that he is a member of the steering board of the nonprofit Foundation to Promote Research Into Functional Vitamin B12 Deficiency. Drs Ueland and Nygård report that they have received consulting fees from Nycomed. No other disclosures were reported.
WENBIT Investigators:Department of Heart Disease, Haukeland University Hospital: Øyvind Bleie, Elfrid Blomdal, Carmen Dybdal, Janne Dyngeland, Tove Sell Dyngeland, Britt Gjellefall, Marie Husa, Vivi Lill Johannessen, Liv Johanne Karstensen, Sarita Kvamme, Svein Erik Laukli, Ove Netland, Janne Nilsen, Ottar Nygård, Elisabeth Norheim, Elin Strand, Linda Træet, Britt Jeanette Ulvatn, Marie Vik, Ove Årseth; Department of Cardiology, Stavanger University Hospital: Reidun Meling, Dennis W. Nilsen, Selma Ramstrøm, Hellen Svalestad; Steering Committee: Ottar Nygård (chair), Per Magne Ueland, Jan Erik Nordrehaug, Dennis W. Nilsen, Stein Emil Vollset, Helga Refsum; End-Points Committee: Per Lund-Johansen, MD, PhD (chair), Section for Cardiology, Institute of Medicine, University of Bergen and Haukeland University Hospital; Leik Woie, MD (consultant cardiologist), Department of Cardiology, Stavanger University Hospital; Marta Ebbing, MD, Department of Heart Disease, Haukeland University Hospital; Safety Committee: Rolv T. Lie, PhD (chair), Section for Epidemiology and Medical Statistics, Department of Public Health and Primary Health Care, University of Bergen; Terje R. Pedersen, MD, PhD, Centre for Preventive Medicine, Ullevål University Hospital, Oslo, Norway.
Funding/Support: This trial was funded by the Advanced Research Program and Research Council of Norway, the Norwegian Foundation for Health and Rehabilitation, the Norwegian Heart and Lung Patient Organisation, the Norwegian Ministry of Health and Care Services, the Western Norway Regional Health Authority, the Department of Heart Disease at Haukeland University Hospital, Locus for Homocysteine and Related Vitamins at the University of Bergen, Locus for Cardiac Research at the University of Bergen, the Foundation to Promote Research Into Functional Vitamin B12 Deficiency, Bergen, Norway, and Alpharma Inc, Copenhagen, Denmark.
Role of the Sponsors: The main sponsors were nonprofit organizations with no participating role in the trial. Alpharma Inc provided the study capsules, generated the randomization sequence, and concealed the randomization code free of charge and rendered a limited grant to finance the initial phase of the trial. However, Alpharma Inc had no role in the design or implementation of the trial, had no access to study data, and did not participate in data analysis or interpretation or in the preparation, review, or approval of the manuscript.
Additional Contributions: We thank the recruiting physicians, study nurses, laboratory personnel, and other coworkers at Haukeland University Hospital and Stavanger University Hospital. We especially thank study nurse Janne Dyngeland, Department of Heart Disease, Haukeland University Hospital, and chief engineer Gry Kvalheim, Section for Pharmacology, Institute of Medicine, University of Bergen and Haukeland University Hospital, for excellent coordinating work, both of whom were compensated. Finally, we thank all participants for their time and motivation.