Accepted for Publication: March 4, 2014.
Published Online: May 5, 2014. doi:10.1001/jamainternmed.2014.1232.
Study concept and design: Bauer, Cummings, Black.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Bauer.
Critical revision of the manuscript for important intellectual content: Schwartz, Palermo, Cauley, Hochberg, Santora, Cummings, Black.
Statistical analysis: Palermo, Black.
Obtained funding: Cummings, Black.
Administrative, technical, or material support: Bauer, Cauley, Cummings.
Study supervision: Bauer, Cummings, Black.
Conflict of Interest Disclosures: Dr Schwartz has consulted for Merck. Ms Palermo has consulted for Nycomed. Dr Cauley has consulted for Merck. Dr Hochberg has consulted for Merck, Amgen, and Eli Lilly. Dr Santora is employed by Merck. Dr Cummings has consulted for Amgen, Eli Lilly, GlaxoSmithKline, and Merck. Dr Black has consulted for Amgen and Eli Lilly and has received honoraria from Amgen, Merck, and Novartis. No other disclosures are reported.
Funding/Support: The FLEX study was supported by contracts from Merck & Co; this analysis was designed and conducted by the non-Merck investigators without additional financial support. The study drug was manufactured and packaged by Merck.
Role of the Sponsor: Merck 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.