Study oversight
The study protocol was approved by institutional review boards of the authorities in Germany (Paul-Ehrlich-Institute) and the Netherlands (Central Committee on Research involving Human Subjects). The study was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonization guidelines for Good Clinical Practice. Written informed consent was obtained from all patients. Initial drafts of the manuscript were prepared by a subset of the authors and all authors contributed to the final manuscript. All authors made the decision to submit the manuscript for publication.