Ethics and regulatory requirements
This study was carried out in accordance with the Declaration of Helsinki and the International Conference on Harmonization and Good Clinical Practice (ICH-GCP) E6 (R2) guidelines. The study was approved by the Paul Ehrlich Institut (Federal Institute for Vaccines and Biomedicines) and the ethics committee of the Medical Faculty Heidelberg. Regulatory authority requirements with respect to plasma manufacturing, according to §67 Arzneimittelgesetz (Germany) and §13 GCP-V, were met.