Author Contributions: Dr O’Donnell 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. Drs O’Donnell and Yusuf contributed equally to this article (joint first authors).
Study concept and design: O’Donnell, Yusuf, Manns, Sleight, Dans, Schmieder.
Acquisition of data: O’Donnell, Yusuf, Manns, Teo, McQueen, Dans, Probsfield.
Analysis and interpretation of data: O’Donnell, Yusuf, Mente, Gao, Manns, Teo, Sleight, McQueen, Sharma, Dans.
Drafting of the manuscript: O’Donnell, Yusuf, Gao, Schmieder.
Critical revision of the manuscript for important intellectual content: O’Donnell, Yusuf, Mente, Manns, Teo, Sleight, McQueen, Sharma, Dans, Probsfield, Schmieder.
Statistical analysis: O’Donnell, Yusuf, Mente, Gao.
Administrative, technical, or material support: O’Donnell, Yusuf, Manns, Teo, McQueen, Sharma, Probsfield.
Study supervision: O’Donnell, Yusuf, Manns, Teo, Sleight, Probsfield, Schmieder.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs O’Donnell, Yusuf, Teo, Sleight, Sharma, Dans, and Schmieder report receipt of consulting and lecture fees and research grants from Boehringer Ingelheim and from other companies manufacturing angiotensin II receptor blockers (pending completion) and receipt of support for travel to meetings for the study or other purposes from Boehringer Ingelheim. Dr Sleight reports receipt of fees for participation in review activities such as data monitoring boards, statistical analysis, and end point committees, and payment for service on the speakers bureau from Boehringer-Ingelheim. Dr McQueen reports pending grants from Sanofi-aventis. Dr Sharma reports receipt of consultancy fees from Abbott Laboratories, Merck, Arena, Vivus, Novo-Nordisk, Sanofi-aventis, GlaxoSmithKline, NeuroSearch, and Allergan; payment for expert testimony from GlaxoSmithKline; grants or pending grants from Abbott Laboratories; payment for service on speakers bureaus from Boehringer-Ingelheim, Abbott Laboratories, Novo-Nordisk, Allerban, Johnson & Johnson, and Sanofi-aventis; and reimbursement for travel/accommodations expenses from various companies. Dr Dans reports receipt of payment for service on the speakers bureau from Boehringer Ingelheim. Dr Probstfield reports receipt of consultancy fees from Eli Lilly, Sanofi-aventis, and Genentech; and grants or pending grants from Eli Lilly, Sanofi-aventis, and Abbott Laboratories. Dr Schmieder reports receipt of fees for participation in review activities such as data monitoring boards, statistical analysis, and end point committees from Boehringer Ingelheim. Drs Mente, Gao, and Mann report no disclosures.
Funding/Support: The study was supported by Boehringer-Ingelheim.
Role of the Sponsor: Boehringer-Ingelheim had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Independent Statistical Analysis: All statistical analyses were performed by Peggy Gao, MSc, Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
Online-Only Material: The Author Audio Interview is available here.