Author Contributions: Dr Grinspoon had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Koutkia, Lee, Grinspoon.
Acquisition of data: Lo, You, Canavan, Liebau, Beltrani, Koutkia, Hemphill, Grinspoon.
Analysis and interpretation of data: Lo, You, Canavan, Lee, Grinspoon.
Drafting of the manuscript: Lo, You, Canavan, Koutkia, Lee, Grinspoon.
Critical revision of the manuscript for important intellectual content: Lo, You, Canavan, Liebau, Beltrani, Hemphill, Lee, Grinspoon.
Statistical analysis: Lo, You, Canavan, Lee.
Obtained funding: Grinspoon.
Administrative, technical, or material support: You, Canavan, Liebau, Beltrani, Koutkia, Hemphill.
Study supervision: Grinspoon.
Financial Disclosures: Dr Grinspoon reports receiving research support on an unrelated project from EMD Serono and also serving as a consultant for EMD Serono. In addition, Dr Grinspoon reports serving as a consultant and has received research support from Theratechnologies. No other authors reported any financial disclosures.
Funding/Support: This study was funded by grants R01 DK63639 (Dr Grinspoon), F32 HL088991 (Dr Lo), and M01 RR01066-25S1 from the National Institutes of Health. EMD Serono provided the growth hormone (Serostim) and placebo but did not provide funding for the study.
Role of the Sponsors: The National Institutes of Health reviewed the design of the study and annual progress reports, but did not participate in the conduct of the study, in the collection, management, analysis, or interpretation of the data, or in the preparation, review, or approval of the manuscript. EMD Serono played no part in the study design, conduct, analysis, or decisions about manuscript submission.
Previous Presentations: Presented in part at the Conference of Retroviruses and Opportunistic Infections; February 6, 2008; Boston, Massachusetts; and at the Endocrine Society; June 17, 2008; San Francisco, California.
Additional Contributions: We thank the patients for their participation and the General Clinical Research Center nursing and bionutrition staff of the Massachusetts General Hospital and Massachusetts Institute of Technology for their dedicated care of the patients.