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Article History

Received: 16 May 2024

Accepted: 13 January 2025

First Online: 27 January 2025

Declarations

:

: The study is planned and performed in accordance with the Declaration of Helsinki 2013, the EU Clinical Trial Directive 2001/20/ EC that will be replaced by the new EU Clinical Trial Regulation 536/ 2014 after transition in August 2024, the German Drug Law (Arzneimittelgesetz) in the current version as well as in accordance with the Good Clinical Practice (GCP) principles.The study protocol, the patient information sheet and the informed consent form were submitted to all involved ethics committees and approved before study start. In parallel, necessary documents were submitted to the competent authority (Paul-Ehrlich-Institute) for approval. The approval of both parties were mandatory for study conduct and recruiting of patients. The current study protocol version 5.0 of February 2024 was approved by the independent leading ethics committee (Ethik-Kommission der Ärztekammer Hamburg; 2021–100714-AMG-ff) and competent authority on the 21st of March 2024 and on the 26th of March 2024, respectively.Written informed consent from each patient is mandatory before any study treatments will be performed. The investigator explain the nature, significance and implications of the study. All methods, rules of conduct and any restrictions which may apply will be explained. Possible effects and side effects will be discussed. Patients will be informed that they are free to withdraw from the study at any time, without giving any reason.

: Not applicable.

: The authors declare no competing interests.