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Article History

Received: 11 September 2023

Accepted: 16 November 2023

First Online: 11 December 2023

Declarations

:

: This study will be conducted in compliance with the principles of the declaration of Helsinki, the Medical Research involving human subjects act (WMO), and the General Data Protection Regulation (GDPR). The competent authorities in charge are permitted to carry out inspections of the study in compliance with relevant legislation. Sponsor’s representatives may conduct quality assurance audits at the participating institutions at any time. The coordinating center consists of a daily study management group, including RK, BT, BR, and MvdB. The group will meet weekly. This study does not have a trial steering committee. The study has been approved by the Radboud University Medical Center research ethics committee (2022–16133). Written informed consent for the MONITOR-IC study will be obtained from all participants or their legal representatives prior to enrolment. Consent on the use of data in ancillary studies is provided with the informed consent for the study. This study does not offer provision for ancillary care. Any important protocol amendments will be communicated timely to relevant parties. The study is registered in the ClinicalTrials.gov database (NCT05783505). Results of this study will be published in international peer reviewed scientific journals and presented at (inter)national congresses. The authorship policy will follow the ICMJE criteria for academic publications ().

: Not applicable.

: The authors declare that they have no competing interests.