Document is current

Article History

Received: 4 January 2021

Accepted: 2 July 2021

First Online: 22 July 2021

Declarations

:

: This clinical trial will be conducted and reported in compliance with GCP and the applicable national laws and regulations and with the ethical principles laid down in the Declaration of Helsinki to assure that the rights, safety, and well-being of the participating subjects are protected.The clinical trial protocol and any required documents were approved by the German Competent Authority, by the Ethics Committee of the University of Halle-Wittenberg, Germany (reference number 2020-011), and by independent Ethics Committees of all trial sites before the trial start.Participation in the clinical trial is voluntary for all patients. All patients are informed about the nature, significance, and scope of the study; possible benefits and risks of the treatment; the rights and responsibilities of study participants; and the transmission of collected data by the investigator.

: All investigational materials and data will be pseudonymized with a unique patient ID before submission to the sponsor and scientific processing. The data has to be saved at least for 10 years in accordance with GCP regulations.

: The authors declare that they have no competing interests.