Ethical considerations
Ärztliche
According to the Medical Association’s Professional Code of Conduct “Ärztliche Berufsordnung” of each participating German state, an independent Ethics Committee (IEC) must be consulted before the start of the clinical study concerning questions relating to professional ethics and legal issues, which are associated with the study. For this purpose, the study protocol, patient information sheet, and informed consent must be submitted to the responsible Ethics Committee.The trial will be conducted in line with the Declaration of Helsinki in its current version and with the laws and declaration of the concerned country. This protocol is designed to ensure that the study is carried out and analysed according to ICH-GCP. The trial is in line with the Consort Guidelines [