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Footnotes
STATEMENT OF POTENTIAL CONFLICT OF INTEREST No potential conflict of interest was reported by the authors.
FUNDING/SUPPORT This research was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Intramural Research Program (contract #HHSN275201300015C and #HHSN275201300026I/HHSN27500002).
This study was registered at ClinicalTrials.gov, NCT02217462, on August 13, 2014.
AUTHOR CONTRIBUTIONS T. Nansel provided study oversight; all authors designed the research; K. Burger conducted the research; L. Lipsky performed statistical analysis and wrote the manuscript; all authors revised critically; and L. Lipsky, T. Nansel, and K. Burger had primary responsibility for final content. All authors read and approved the final manuscript.