Author Contributions: Dr Armitage 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: Armitage, Parish, Sleight, Peto, Collins.
Acquisition of data: Armitage, Bowman, Wallendszus, Bulbulia, Rahimi, Haynes, Peto, Collins.
Analysis and interpretation of data: Armitage, Bowman, Clarke, Wallendszus, Parish, Peto, Collins.
Drafting of the manuscript: Armitage, Bowman, Peto, Collins.
Critical revision of the manuscript for important intellectual content: Clarke, Wallendszus, Bulbulia, Rahimi, Haynes, Parish, Sleight, Peto, Collins.
Statistical analysis: Wallendszus, Parish, Peto, Collins.
Obtained funding: Peto, Collins.
Administrative, technical, or material support: Armitage, Bowman, Clarke, Wallendszus, Bulbulia, Rahimi, Haynes, Peto, Collins.
Study supervision: Armitage, Parish, Peto, Collins.
Financial Disclosures: The Clinical Trial Service Unit (CTSU) reported having a staff policy of not accepting honoraria or other payments from the pharmaceutical industry, except for the reimbursement of costs to participate in scientific meetings. The CTSU members of the writing committee have, therefore, only had such costs reimbursed. Dr Sleight reported receiving speaker or data safety monitoring board fees from the following companies: Abbott, AstraZeneca, Aventis, Bayer, Boehringer-Ingelheim, Boehringer Mannheim, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Knoll, Medscape, Menarini, Merck, Monarch, MSD, Novartis, Pfizer, Pharmacia, Sanofi, and Servier. The CTSU reported receiving grants from Merck as well as from various other pharmaceutical companies to conduct independent research.
Funding/Support: The study was funded by Merck (manufacturers of simvastatin and suppliers of the vitamins). The CTSU also receives core support from the UK Medical Research Council and the British Heart Foundation.
Role of the Sponsors: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript. The University of Oxford acted as the sponsor of the study. Data analysis was performed by an Oxford University senior academic biostatistical programmer (Mr Wallendszus) under the supervision of the senior statistician (Dr Parish) and principal investigators (Dr Collins, Mr Peto, and Dr Armitage).
Additional Contributions: The most important acknowledgment is to the participants in the study and to the doctors, nurses, and administrative staff in hospitals and general practices throughout the United Kingdom who assisted with its conduct. The salary costs of the nurses working on the study were funded from the study grant, but none of the doctors or participants were paid (although travel costs could be reimbursed).
A list of the SEARCH Collaborative Group members appears in the eAppendix.