Study concept and design: Stanley, Lee, Grinspoon.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Stanley, Feldpausch, Oh, Lee, Torriani, Grinspoon.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Stanley, Feldpausch, Lee, Grinspoon.
Obtained funding: Grinspoon.
Administrative, technical, or material support: Stanley, Feldpausch, Oh, Branch, Torriani.
Study supervision: Grinspoon.
Conflict of Interest Disclosures: Dr Grinspoon reports serving as a consultant to Aileron Therapeutics Inc, Ferrer, sanofi-aventis, Navidea, AstraZeneca, and EMD Serono Inc and receipt of investigator-initiated research funds from Theratechnologies Inc, Bristol-Myers Squibb, Gilead, Amgen/Immunex, Novo Nordisk, and Serono. No other disclosures were reported.
Funding/Support: Funding was provided by National Institutes of Health grants K23DK089910 to Dr Stanley and R01DK063639 to Dr Grinspoon and by grants M01-RR-01066 and 1 UL1 RR025758-01 to the Harvard Clinical and Translational Science Center from the National Center for Research Resources. The study was also supported in part by the Nutrition Obesity Research Center, Harvard University (National Institutes of Health grant P30 DK40561). Study drug was provided by Theratechnologies Inc.
Role of the Sponsors: The study funders had no role in the design or conduct of the study; collection, management, analysis, and interpretation of the data; preparation of the manuscript; or decision to submit the manuscript for publication. Theratechnologies reviewed the manuscript prior to submission, but submission was not contingent on approval by Theratechnologies.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.
Previous Presentations: Data from this study were presented at the 2014 Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts, March 3-6, 2014, and the 2014 Endocrine Society meeting, Chicago, Illinois, June 21-24, 2014.
Additional Contributions: We gratefully acknowledge the research volunteers for their participation in the study, the Massachusetts General Hospital bionutrition and nursing staffs for their dedicated patient care, and the members of the data and safety monitoring board for their time and commitment to patient safety.