Final version of study protocol as approved by first regulatory/ethics committee (Package 1)

The clinical trial documents will be submitted to the competent authorities and the ethical review boards. The partners LMU, OPBG, LUMC, CHU, UNEW, UZG are involved in this task. The task leader LMU will submit the trial to the German competent authority Paul-Ehrlich-Institut. The role of all other participants (OPBG, LUMC, CHU, UNEW, UZG) will be to submit the trial to their national and local authorities. Deliverables D 2.5 and 2.6 are the outcome of this task, which will contain the whole submission package, including the final version of the study protocol as approved by competent authorities.