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Article History

Received: 21 November 2024

Accepted: 6 January 2025

First Online: 10 January 2025

Declarations

:

: Ethics approval to start inclusion of patients for cohort 1 was granted by the ethics committee of the Erasmus MC (MEC-number: MEC-2022-0473, version 2.0, dated 13-12-2022). Ethical approval for the initiation of cohort 2 is granted by the ethics committee of the Erasmus MC (MEC-number: MEC-2024-0621, version 1.0, dated 27-08-2024). All participants will be required to provide their informed consent in writing before inclusion in the study. Any protocol modifications will be submitted as an amendment to the ethics committee and updated in Clinical Trial registry. These changes to the research will be made after a favourable opinion by the accredited ethics committee of the Erasmus MC. The study will be conducted according to the principles of the Declaration of Helsinki, Gedragscode Gezondheidsonderzoek 2022 and in accordance with the Erasmus MC Research Code and General Data Protection Regulation. Given the very low-risk nature of this study and that it is classified as Non-WMO, we did not establish a Data Monitoring Committee, report adverse events, or conduct auditing. The METC has approved this approach. Handling of personal data will comply with the Dutch Personal Data Protection Act. All data will be processed digitally, in a protected area. Subjects, and their data will be coded by a serial number (patient identification code), which is not based on the patient initials or birthdate. We will use a subject identification code list to link the data to the subject. Data will be stored in a secured folder and additionally secured by a password. Only the executive researchers and research coordinator will have access to the key.

: Not applicable.

: The authors declare no competing interests.