Author contributions
MP, FM
EP, MP, JE, and FM: conceptualization and methodology, writing—review and editing, and project administration.. TM: statistics. EP and MP: coordinating clinical investigators. EP, MP, JE, FM, AK, MG, JO-S, IK, JL-A, and ES: writing and original draft preparation. All authors contributed to the writing—review and editing, article, and approved the submitted version.The authors thank Dr. Egmont Zieseniß, Inpharm Consulting, Dortmund, Germany, for performing the study monitoring.