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Article History

Received: 23 April 2024

Accepted: 27 September 2024

First Online: 8 October 2024

Declarations

:

: This study was performed in accordance with the study protocol, the ethical principles stated in the Declaration of Helsinki as well as those indicated in the International Conference on Harmonization (ICH) Note for Guidance on Good Clinical Practice (GCP; ICH E6, 1995), and all applicable regulatory requirements. All patients had to sign a written informed consent form before entering the study. Adequate information was given to eligible patients by the principal investigator or co-investigators at each participating Centre and in accordance with local regulations. Written informed consent to participate in the clinical study had to be given before any study-related activities were carried out. The declaration of informed consent was personally signed and dated by the subject and by the investigator/person designated by the investigator to conduct the informed consent discussion.

: Patients provided written consent before engaging in study-related activities or providing study data.

: Patients signed an informed consent regarding the publishing of their data.

: The authors declare no competing interests.