Study concept and design: Coovadia, Abrams, Kuhn.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Coovadia, Kuhn.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Shiau, Tsai, Kuhn.
Obtained funding: Coovadia, Abrams, Kuhn.
Administrative, technical, or material support: Coovadia, Abrams, Hunt, Kuhn.
Study supervision: Coovadia, Abrams, Kuhn.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: The study was supported by grant HD061255 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Role of the Funder/Sponsor: The funders 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; or decision to submit the manuscript for publication.
Previous Presentation: An abstract of this report was presented at the Conference on Retroviruses and Opportunistic Infections; Boston, Massachusetts; March 5, 2014.
Additional Contributions: We thank Lynne Mofenson, MD (formerly of the Eunice Kennedy Shriver National Institute for Child Health and Human Development), for assistance with the study, as well as the members of the data and safety monitoring board: Mark Cotton, MD (Stellenbosch University), Brian Eley, MD (University of Cape Town), Mary-Glenn Fowler, MD (Johns Hopkins University), Carl Lombard, PhD (South African Medical Research Council), Paul E. Palumbo, MD (Geisel School of Medicine at Dartmouth), and Avy Violari, MD (Perinatal HIV Research Unit). The named individuals were not compensated for their participation. We also thank all members of the study team in South Africa and New York. We appreciate the dedication and commitment to the study of the participants and their caregivers.