Group Information: A list of the SOLID-TIMI 52 Investigators is included in Supplement 1.
Published Online: August 31, 2014. doi:10.1001/jama.2014.11061.
Study concept and design: O’Donoghue, Braunwald, White, Lukas, Tarka, Hochman, Bode, Davies, Crugnale, Watson, Serruys, Cannon.
Acquisition, analysis, or interpretation of data: O’Donoghue, Braunwald, Steen, Lukas, Tarka, Steg, Im, Shannon, Davies, Murphy, Wiviott, Bonaca, Watson, Weaver, Cannon.
Drafting of the manuscript: O’Donoghue, Steen, Im, Murphy.
Critical revision of the manuscript for important intellectual content: O’Donoghue, Braunwald, White, Steen, Lukas, Tarka, Steg, Hochman, Bode, Shannon, Davies, Murphy, Wiviott, Bonaca, Weaver, Serruys, Cannon.
Statistical analysis: O’Donoghue, Steen, Im, Shannon, Davies, Murphy, Cannon.
Obtained funding: Braunwald, Cannon.
Administrative, technical, or material support: Steen, Crugnale, Bonaca, Watson, Cannon.
Study supervision: O’Donoghue, Braunwald, White, Steen, Lukas, Tarka, Steg, Bonaca, Watson, Weaver, Serruys, Cannon.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr O’Donoghue reports institutional grants from GlaxoSmithKline, Eisai, and AstraZeneca; honoraria from diaDexus; and consulting fees from Aegerion. Dr Braunwald reports grants to his institution from GlaxoSmithKline during the conduct of the study; and for outside the submitted work, a grant to his institution from Merck Sharpe & Dohme, Bristol-Myers-Squibb, Duke University, AstraZeneca, Johnson & Johnson, and Sanofi-Aventis; uncompensated consultancies and lectures for Merck Sharpe & Dohme; consultancies with The Medicines Company and Sanofi-Aventis; and honoraria for lectures from Menarini International, Medscape, Bayer, and Daiichi Sankyo. Dr White reports receipt of grants from Sanofi-Aventis, Eli Lilly, The Medicines Company, National Institutes of Health, Roche, Merck Sharpe & Dohme, AstraZeneca, GlaxoSmithKline, and Daiichi Sankyo; and consultancies with AstraZeneca, Merck Sharpe & Dohme, Roche, and Regado Biosciences. Dr Steen reports receipt of consulting fees from Regeneron and Sanofi-Aventis. Drs Tarka and Lukas, and Messrs Davies and Watson report receipt of personal fees from GlaxoSmithKline during the conduct of the study and also receipt of personal fees from GlaxoSmithKline outside the submitted work. Drs Tarka and Lukas, Messrs Davies and Watson, and Ms Shannon report being employees of GlaxoSmithKline. Dr Steg reports receipt of honoraria from GlaxoSmithKline for steering committee membership; and personal fees from Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers-Squibb, Daiichi-Sankyo, GlaxoSmithKline, Lilly, Merck Sharpe & Dohme, Novartis, Otsuka, Pfizer, Roche, Sanofi-Aventis, Servier, The Medicines Company, and Vivus; research grants from the NYU School of Medicine, Sanofi-Aventis, and Servier; and stockholdership in Aterovax. Dr Hochman reports receipt of honoraria from GlaxoSmithKline during the conduct of the study. Dr Bode reports receipt of personal fees from AstraZeneca, Bayer, Boehringer-Ingelheim, Daiichi Sankyo, and Sanofi-Aventis. Dr Maggioni reports receipt of honoraria from GlaxoSmithKline; and grants for steering committee participation from Novartis, Bayer, Abbott Vascular, Cardiorentis. Mss Murphy and Crugnale report receipt of grants from GlaxoSmithKline, during the conduct of the study. Dr Wiviott reports receipt of research grants and consulting fees from AstraZeneca, Bristol-Myers-Squibb, Eisai, Arena, and Eli Lilly/Daiichi Sankyo; research grants from Merck Sharpe & Dohme and Sanofi-Aventis; consulting fees from Aegerion, Angelmed, Janssen, Xoma, ICON Clinical, and Boston Clinical Research Institute; and grants from GlaxoSmithKline during the conduct of the study. Dr Bonaca reports receipt of a research grant to the TIMI Study Group from GlaxoSmithKline and consulting fees from AstraZeneca and Merck Sharpe & Dohme. Dr Weaver reports receipt of personal fees from GlaxoSmithKline for the cost of attending study meetings and from the TIMI Group for executive steering committee meetings. Dr Cannon reports receipt of grant support from Accumetrics, Arisaph, AstraZeneca, Boehringer-Ingelheim, Janssen, Merck Sharpe & Dohme, and Takeda; and receipt of personal fees from CSL Behring, Essentialis, Merck Sharpe & Dohme, Regeneron, Sanofi-Aventis, Takeda, Lipimedix, BMS, and Pfizer. No other disclosures were reported.
Funding/Support: The SOLID-TIMI 52 trial was funded by GlaxoSmithKline.
Role of the Sponsors: The trial was sponsored by GlaxoSmithKline and the protocol was designed by the TIMI Study Group jointly with the executive steering committee and study sponsor. The sponsor developed the statistical analysis plan jointly with the TIMI Study Group. In addition to the sponsor, the TIMI Study Group conducted all primary analyses independently using raw data (K.I. and S.A.M.) and assumes responsibility for the accuracy of the data reported in this manuscript. The manuscript was drafted by the TIMI Study Group (M.L.O.) and reviewed for intellectual content by all of the coauthors. The sponsor reviewed the manuscript and made nonbinding suggestions for consideration.
Correction: This article was corrected online September 15, 2014, for an error in the byline and in the Figure 2 title and legend.