Author Contributions: Dr Kuhn 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: Coovadia, Abrams, Meyers, Kuhn.
Acquisition of data: Coovadia, Strehlau, Meyers, Martens, Sherman, Hunt, Morris, Kuhn.
Analysis and interpretation of data: Abrams, Hunt, Hu, Tsai, Morris, Kuhn.
Drafting of the manuscript: Abrams, Kuhn.
Critical revision of the manuscript for important intellectual content: Coovadia, Abrams, Strehlau, Meyers, Martens, Sherman, Hunt, Hu, Tsai, Morris.
Statistical analysis: Hunt, Hu, Tsai, Kuhn.
Obtained funding: Coovadia, Meyers, Kuhn.
Administrative, technical, or material support: Coovadia, Strehlau, Martens, Sherman, Morris, Kuhn.
Study supervision: Coovadia, Abrams, Morris, Kuhn.
Financial Disclosures: None reported.
Funding/Support: The study was supported by grants from the National Institute of Child Health and Human Development (HD 47177) and Secure the Future Foundation.
Role of the Sponsor: The funders had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Previous Presentation: These data were presented in part (abstract MOAB103) at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention; July 20, 2009; Cape Town, South Africa.
Additional Contributions: We would like to thank the members of the data and safety monitoring board: Edmund Caparelli, MD (University of California, San Diego); Mark Cotton, MD (University of Stellenbosch, South Africa); Victor DeGruttola, PhD (Harvard University, Boston, Massachusetts); Brian Eley, MD (University of Cape Town, South Africa); Mary-Glenn Fowler, MD (Johns Hopkins University, Baltimore, Maryland); Paul Palumbo, MD (Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire); and Andrea Ruff, MD (Johns Hopkins University). We would also like to thank the following people for assistance with scientific aspects of the study: Lynne Mofenson, MD, and Kevin Ryan, PhD (National Institute of Child Health and Human Development, Bethesda, Maryland) and Deborah Persaud, MD (Johns Hopkins University). None of the individuals named here received compensation from the study. We appreciate the dedication of the participants and their caregivers and the clinical and administrative study team.