Study concept and design: Udell, Bhatt, Farkouh, Cannon.
Acquisition of data: Udell, Zawi, Keshtkar-Jahromi, Gaughran, Phrommintikul, Ciszewski, Vakili.
Analysis and interpretation of data: Udell, Bhatt, Keshtkar-Jahromi, Ciszewski, Vakili, Hoffman, Farkouh, Cannon.
Drafting of the manuscript: Udell.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Udell, Keshtkar-Jahromi, Ciszewski, Vakili, Hoffman.
Administrative, technical, or material support: Udell, Zawi, Gaughran, Cannon.
Study supervision: Bhatt, Cannon.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Bhatt reports serving on the advisory board for Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; serving on the board of directors for Boston VA Research Institute and the Society of Cardiovascular Patient Care; serving as chair for the American Heart Association Get With The Guidelines steering committee; receiving honoraria from the American College of Cardiology, Belvoir Publications, Duke Clinical Research Institute, Population Health Research Institute, Slack Publications, and WebMD; serving as a senior associate editor for the Journal of Invasive Cardiology; serving on data monitoring committees for Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and the Population Health Research Institute; receiving grant funding from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Medtronic, sanofi-aventis, and The Medicines Company; and conducting research for FlowCo, PLx Pharma, and Takeda. Dr Gaughran reports receiving grant funding from Guys and St Thomas’ Charitable Trustees and Abbott; receiving honoraria from various pharmaceutical companies for advisory, consultation or lecturing work in the field of mental health, including Bristol-Myers Squibb, Lundbeck, Roche, and Sunovion; and having a family member with professional affiliations to Eli Lilly and GlaxoSmithKline. Dr Vakili reports receiving grant funding from Shahid Beheshti University. Dr Farkouh reports consulting for AstraZeneca, Eli Lilly, Pfizer, sanofi-aventis; and receiving grant funding from Merck. Dr Cannon reports serving on a data safety and monitoring board for a trial sponsored by Merck; consulting for Alnylam, Bristol-Myers Squibb, CSL Behring, Lipimedix, and Pfizer; serving as clinical advisor and equity shareholder for Automedics Medical Systems; receiving grant funding from Accumetrics, AstraZeneca, Essentialis, GlaxoSmithKline, Merck, Regeneron, sanofi-aventis, and Takeda; and receiving reimbursement for travel accommodations from AstraZeneca, GlaxoSmithKline, Merck, Regeneron, sanofi-aventis, and Takeda. No other disclosures were reported.
Funding/Sponsor: Dr Udell is supported by a Canadian Institutes for Health Research and Canadian Foundation for Women’s Health postdoctoral research fellowship award.
Role of the Sponsor: The Canadian Institutes for Health Research and the Canadian Foundation for Women’s Health had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank Mona Frantzke, MLSc (Health Sciences Library, Women’s College Hospital), for providing assistance in the literature search; Jos Nauta, MSc (Abbott), for providing unpublished data from the trial by de Bruijn et al; Carlos A. DiazGranados, MD, MSc (Sanofi Pasteur), for providing unpublished data from the trials by Falsey et al and DiazGranados et al; Rob Lambkin-Williams, PhD (Retroscreen Virology), for providing unpublished data from the FEVER trial; and Herve Caspard, MD, ScD (MedImmune), and Bruce D. Forrest, MD, MBA (B D Forrest & Company), for providing unpublished data from the trials by De Villiers et al and Forrest et al. No compensation was received by any individual for assistance with this study.