1 Center for Pediatric Therapeutics and Regulatory Science, and Computational Health Informatics Program, Boston Children's Hospital, Boston, MA, USA; Program on Regulation, Therapeutics, and Law, and Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA, USA.
2 European Medicines Agency, London, UK.
3 Center for Pediatric Therapeutics and Regulatory Science, and Computational Health Informatics Program, Boston Children's Hospital, Boston, MA, USA; Department of Pediatrics, Harvard Medical School, Boston, MA 02115, USA. Electronic address: [email protected].