Accepted for Publication: February 18, 2014.
Published Online: April 14, 2014. doi:10.1001/jamainternmed.2014.946.
Study concept and design: Davidson, Lensing, Gebel, Prins.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Davidson, Verheijen, Lensing, Brighton, Lyons, Prins.
Critical revision of the manuscript for important intellectual content: Davidson, Lensing, Gebel, Brighton, Lyons, Rehm, Prins.
Statistical analysis: Davidson, Lensing, Gebel, Prins.
Administrative, technical, or material support: Davidson, Lensing, Prins.
Study supervision: Davidson, Lensing.
Conflict of Interest Disclosures: Drs Davidson and Prins were paid by Bayer for steering committee and related work for the EINSTEIN studies. Drs Brighton, Lyons, and Rehm, site principal investigators in the EINSTEIN studies, were paid for time and costs of patient recruitment and follow-up, and Dr Rehm has been a paid speaker for a sponsor, Janssen Pharmaceuticals. All attended EINSTEIN-related meetings with travel-related costs paid by Bayer. No other disclosures are reported.
Funding/Support: Drs Lensing and Gebel are paid employees of Bayer and devoted salaried time to this work; the other authors were unsupported.
Role of the Sponsors: Bayer Healthcare reviewed the manuscript, but Bayer Healthcare and Janssen Pharmaceuticals had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation of the manuscript; and decision to submit the manuscript for publication. Bayer Healthcare and Janssen Pharmaceuticals sponsored the 2 EINSTEIN clinical trials, collected and maintained the data, and performed the analyses that the authors requested. The sponsors’ other roles are described in the original EINSTEIN publications.
Previous Presentation: This study was presented at the 24th Congress of the International Society on Thrombosis and Haemostasis; July 2, 2013; Amsterdam, the Netherlands.