1 Office of Anti-Infectives and Vaccines, Human Medicines Evaluation Division, European Medicines Agency, 1083 HS Amsterdam, The Netherlands. eric.pelfrene@ema.europa.eu.
2 Regulatory Affairs Office, Human Medicines Evaluation Division, European Medicines Agency, 1083 HS Amsterdam, The Netherlands.
3 Office of Anti-Infectives and Vaccines, Human Medicines Evaluation Division, European Medicines Agency, 1083 HS Amsterdam, The Netherlands.