Accepted for Publication: June 12, 2014.
Published Online: August 11, 2014. doi:10.1001/jamainternmed.2014.3634.
Study concept and design: Hue, Cummings, Barrett-Connor, Black.
Acquisition, analysis, or interpretation of data: Hue, Cummings, Cauley, Bauer, Ensrud, Black.
Drafting of the manuscript: Hue, Cummings.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Black.
Obtained funding: Cummings, Barrett-Connor, Black.
Administrative, technical, or material support: Hue, Cauley, Black.
Study supervision: Cummings, Black.
Conflict of Interest Disclosures: Dr Ensrud serves as a consultant on a data monitoring committee for Merck Sharp & Dohme. Dr Black has received grant support from Novartis and Merck and consulting, lecture, or advisory board fees from Lilly, Novartis, Amgen, Radius, and Merck. No other disclosures are reported.
Funding/Support: Support for FIT was provided by Merck & Co, and support for HORIZON-PFT was provided by Novartis, Basel, Switzerland.
Role of the Sponsor: Merck was involved in the design and conduct of the FIT study, and Novartis was involved in the design and conduct of the HORIZON-PFT study. They were also involved in the collection and management of the data in these trials. Merck and Novartis were not involved in the analysis and interpretation of the data for this manuscript, nor were they involved in the preparation, review, or approval of the manuscript, or the decision to submit the manuscript for publication. This analysis was designed and conducted by the non-Merck/non-Novartis investigators without additional financial support.
Additional Contributions: Lisa M. Palermo, MA, MS, University of California, San Francisco, lead analyst for both the FIT and HORIZON-PFT studies, performed the data analysis for this article without additional financial support.
Correction: This article was corrected online September 10, 2014, for an error in the Conflict of Interest Disclosures.