Author Contributions: Dr Martin 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: Ovbiagele, Donnan, Bath.
Acquisition of data: Ovbiagele, Diener, Yusuf, Donnan, Bath.
Analysis and interpretation of data: Ovbiagele, Diener, Yusuf, Martin, Cotton, Vinisko, Donnan, Bath.
Drafting of the manuscript: Ovbiagele, Vinisko, Donnan, Bath.
Critical revision of the manuscript for important intellectual content: Ovbiagele, Diener, Yusuf, Martin, Cotton, Donnan, Bath.
Statistical analysis: Martin, Cotton, Vinisko, Donnan, Bath.
Obtained funding: Diener, Yusuf, Donnan, Bath.
Administrative, technical, or material support: Ovbiagele, Diener, Yusuf, Donnan, Bath.
Study supervision: Diener, Yusuf, Donnan, Bath.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ovbiagele reported that he was paid as a consultant by Avanir Pharmaceuticals for 1-time participation in an experts advisory meeting held in June 2011. Dr Diener reported that he receives honoraria for participation in clinical trials, for contribution to advisory boards or oral presentations, and travel expenses and accommodations from Abbott, Allergan, AstraZeneca, Bayer Vital, Bristol-Meyers Squibb, Boehringer Ingelheim, CoAxia, D-Pharm, ev3 Inc, Fresenius, GlaxoSmithKline, Janssen Cilag, Knoll, MSD (formerly Merck Sharpe Dohme), Medtronic, MindFrame, Neurobiological Technologies, Novartis, Novo-Nordisk, Paion, Parke-Davis, Pfizer, sanofi-aventis, Sankyo, Schering-Plough, Servier, Solvay, Thrombogenics, Wyeth, Yamaguchi. Dr Yusuf reported that he receives grants, consulting and speaker fees, and related travel reimbursement from Boehringer Ingelheim and several other companies that manufacture antihypertensive agents and antiplatelet agents. Messrs Cotton and Vinisko reported that they are employees of Boehringer Ingelheim Pharmaceuticals Inc. Dr Bath reported that he receives honoraria for participation in clinical trials or data monitoring committees, contribution to advisory boards, or oral presentations from Boehringer Ingelheim, Lundbeck, Mitsubishi, and M's Science.
Funding/Support: Boehringer-Ingelheim provided grant monies and materials to execute the Prevention Regimen for Effectively Avoiding Second Strokes (PROFESS) trial.
Role of the Sponsor: Boehringer-Ingelheim had no role in the concept and design of the study; no role in the management, and interpretation of the data; and no role in the preparation or approval of the manuscript. However, employees of Boehringer-Ingelheim (Daniel Cotton and Richard Vinisko) conducted the initial statistical analyses for the study.
Independent Statistical Analysis: Dr Martin received the entire raw PROFESS dataset, independently ran the analysis, and reconciled any differences with the previous analysis. The results reported in this article are those of the independent analyses conducted by Dr Martin.
Additional Contributions: Administrative assistance was provided by Vicky Hinstridge, BPharm (Quercus Medical Communications Ltd), which was contracted and paid for by Boehringer Ingelheim Pharmaceuticals for these services.
A list of the PROFESS Investigators appears in N Engl J Med . 2008;359(12):1238-1251.