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Article History

Received: 6 November 2023

Accepted: 2 September 2024

First Online: 2 October 2024

Declarations

:

: This clinical trial will be conducted in accordance with the principles established by the 18th World Medical Assembly (Helsinki, 1964) and all applicable amendments established by the World Medical Assemblies and the ICH Clinical Practice Guidelines. The study will be conducted in accordance with all international standards and Russian legislation. The protocol of the clinical study, as well as informed consent, were submitted to the ethics committee of the Saint-Petersburg University Hospital on 18.02.2022 г. During the meeting, written approval was received and signed by the chairman and representatives of the ethics committee №02/22 from 24.08.2022. The first version of the study is registered in the United States National Library of Medicine [] NCT03958695 from 09.09.2022 г.All patients participating in this trial will sign an informed consent for the collection and usage of the data obtained by their doctor.Patients that are enrolled in the study are covered by indemnity for negligent harm through the standard arrangements. Saint-Petersburg State University Hospital has insurance to cover for non-negligent harm associated with the protocol. This will include cover for additional health care, compensation, or damages awarded by claims pursued through the courts. Incidences judged to arise from negligence (including those due to major protocol violations) will not be covered by study insurance policies.

: Not applicable, as no identifying images or personal/clinical details of participants are shown here, nor will they be included in the trial results reports.

: The authors declare that we have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.Topics suggested for presentation or publication will be circulated to the <i>Principal investigators</i> of the author group. The writing committee will be formed the person making the suggestion about trial design and main principles may be considered as the lead author. Disputes regarding authorship will be settled by the Study Chair after consultation with the Chair of the authors.