1. Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany;
2. Finnish Medicines Agency, Helsinki, Finland;
3. Paul-Ehrlich-Institut, Langen, Germany;
4. Medicines and Healthcare Products Regulatory Agency, London, United Kingdom;
5. Danish Health and Medicines Authority, Copenhagen, Denmark; and
6. Twincore Centre for Experimental and Clinical Infection Research, Hannover, Germany