Watt, Kevin M.
Avant, Debbie
Sherwin, Jennifer
Benjamin, Daniel K.
Hornik, Christoph
Benjamin, Daniel K. Jr
Li, Jennifer S.
Smith, P. Brian
Funding for this research was provided by:
U.S. Food and Drug Administration
Article History
Received: 3 February 2017
Revised: 13 June 2017
Accepted: 14 June 2017
First Online: 4 August 2017
Compliance with ethical standards
:
: All trials were approved by the institutional review boards of the participating sites. Because the datasets obtained from DARRTS and the EDR contained no patient identifiers, we received a waiver of review from the Duke University Medical Center Institutional Review Board and a letter of exempt status from the FDA Research Involving Human Subjects Committee.
: This study was funded by a grant from the Duke University O’Brien Center for Kidney Research, which is supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and by the Duke University School of Medicine and Department of Medicine.
: The work of KMW was supported under an Intergovernmental Personnel Agreement (IPA) between the US Food and Drug Administration and Duke University.KMW receives support from the National Institute of Child Health and Human Development (NICHD) (1K23HD075891, 5K12HD047349) and the Thrasher Research Fund for his work in pediatric clinical pharmacology. DKB Jr receives support from the National Institutes of Health (NIH) (award 2K24HD058735–06, National Center for Advancing Translational Sciences (NCATS)award UL1TR001117, NICHD contract HSN275201000003I, and National Institute of Allergy and Infectious Diseases [NIAID] contract HHSN272201500006I); he also receives research support from Cempra Pharmaceuticals (subaward to HHSO100201300009C) and industry for neonatal and pediatric drug development (ExternalRef removed). PBS receives salary support for research from the NIH and the NCATS of the NIH (UL1TR001117), the NICHD (HHSN275201000003I and 1R01-HD081044–01), and the Food and Drug Administration (FDA) (1R18-FD005292–01); he also receives research support from Cempra Pharmaceuticals (subaward to HHS0100201300009C) and industry for neonatal and pediatric drug development (ExternalRef removed). The remaining authors have no disclosures. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.