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Article History

Received: 14 November 2022

Accepted: 25 July 2023

First Online: 7 August 2023

Declarations

:

: The trial will be conducted according to the declaration of Helsinki. The trial protocol, the consent form, and related documents were reviewed and approved by the Helsinki and Uusimaa Hospital District Ethical Committee (reference number: HUS/3487/2019). Any protocol amendments will be discussed with the steering committee, reported, and submitted to the Ethics Committee. Written informed consent to participate will be obtained from all participants. The trial protocol was developed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement and registered with ClinicalTrials.gov (identifying number NCT04260165). Anonymity and confidentiality of participants will be ensured, and the trial will adhere to the EU General Data Protection Regulation. Clinical onsite monitoring will be performed by HUCH institute to ensure patient’s rights, patient’s security, and reliability of trial results. All participants will be assured that the trial is voluntary and that withdrawal is allowed at any point. Major AEs will be monitored by the DSMC. Moreover, any unexpected harm caused to patients who are enrolled in the study and that are due to the study interventions or assessments will be covered by the insurance of the participating hospitals.

: No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are available from the corresponding author on request."

: The authors declare that they have no competing interests.