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Article History

Received: 8 November 2023

Accepted: 27 November 2024

First Online: 18 December 2024

Declarations

:

: The study was approved by the Ethics Committee of the National Institute of Cardiovascular Diseases (Approval Number 1625/21, 26th May 2021) and the ClinicalTrials.gov (Trial Registration Number NCT04930302, 16th June 2021). All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable. Written informed consent was obtained from all subjects before the initiation of any research-related activities. The consent form used was approved by the Ethics Committee and was presented in the Slovak language, ensuring participants could read and comprehend it. By signing the informed consent, participants agreed to the publication and presentation of their pseudonymized analysed data.Patients’ personal data were anonymised to ensure confidentiality. The Participant Identification Sheet was securely stored at the study centre along with other documentation. Anonymised data were then entered into the case report form in the online database MIA DMS, which operates in Europe.

: Not applicable.

: The authors declare no competing interests.