The authors are sincerely grateful for Erin Chang, Rose Beci and Kylie Opel for their assistance with the acquisition of the data and their thoughtful contributions to the data analysis process. The authors are also grateful to the International Children’s Advisory Network for their continued partnership and sustained interaction with their members. PTN steering committee members not already named among the authors include: Daniel K. Benjamin Jr., Kanecia Zimmerman, Duke Clinical Research Institute, Durham, NC; Chi Dang Hornik, Duke University Medical Center, Durham, NC; Gregory L. Kearns, Scottsdale, AZ; Matthew Laughon, University of North Carolina at Chapel Hill, Chapel Hill, NC; Ian M. Paul, Penn State College of Medicine, Hershey, PA; Janice Sullivan, University of Louisville, Louisville, KY; Kelly Wade, Children’s Hospital of Philadelphia, Philadelphia, PA; Paula Delmore, Wichita Medical Research and Education Foundation, Wichita, KS; Leanne West, International Children’s Advocacy Network; The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Ravinder Anand, Elizabeth Payne, Lily Chen, Gina Simone, Kathleen O’Connor, Jennifer Cermak, and Lawrence Taylor, The Emmes Company, LLC (Data Coordinating Center).

Susan Abdel-Rahman participated in this work while affiliated with Health Data Synthesis Institute. This article only reflects the views of the authors and should not be construed to represent the views or policies of the U.S. Food and Drug Administration.