2 Division of Hematology Products, Office of Drug Evaluation 1, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland. Electronic address: Ann.Farrell@fda.hhs.gov.
3 Divisions of Hematology, Johns Hopkins School of Medicine, Baltimore, MD, Johns Hopkins Pediatric Thrombosis Program, St. Petersburg, FL, - Baltimore, MD, All Children's Research Institute. Electronic address: neil@jhmi.edu.
4 Duke University, Duke Clinical Research Institute. Electronic address: christoph.hornik@duke.edu.
5 Office of Clinical Trials/ Bureau des Essais Clinique, Centre for Regulatory Excellence, Statistics and Trials/Centre d'Excellence Réglementaire, de Statistiques et Essais Clinique, Ottawa, Ontario, Canada. Electronic address: daniel.keene@canada.ca.
6 Duke University Medical Center. Electronic address: mitchell.krucoff@duke.edu.
7 Janssen Research and Development LLC, Rahway, NJ. Electronic address: clipardi@its.jnj.com.
8 Department of Pediatrics, University of Alberta. Electronic address: Patti.Massicotte@albertahealthservices.ca.