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Article History

Received: 6 May 2024

Accepted: 29 August 2024

First Online: 9 September 2024

Declarations

:

: According to the Executive Board of the Medical Ethics Committee of the Amsterdam Medical Center (AMC), the Medical Research Involving Human Subject Act does not apply to this study (reference number W22_434 # 22.512). The Executive Board of the Medical Ethics Committee had no objection to the execution of the study. Any substantial modifications to the protocol will be promptly communicated to the Medical Ethics Committee. All procedures will be in accordance with the ethical standards of the Helsinki Declaration of 1964 and its later amendments or comparable ethical standards. Participants will be asked to sign informed consent before they participate in the study. While we do not expect any adverse events likely to be caused by our intervention, such events will be documented and reported through the sponsor’s portal at the Amsterdam UMC. Also, serious adverse events will be documented and reported to the ethics committee.

: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.

: The authors declare that they have no competing interests.