Diego F. Wyszynski, MD, MHS, PhD is the Global Safety Director in the division of Global Regulatory Affairs and Safety at Amgen, Inc. in Thousand Oaks, CA Thomas P. Graham, M.D. is a Professor of Pediatric Cardiology at Vanderbilt University in Nashville, TN Adolfo Correa-Villaseñor M.D., M.P.H., Ph.D. is a Medical Epidemiologist at the Birth Defects and Genetic Disease Division of the Center for Disease Control and Prevention