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Article History
Received: 3 February 2025
Revised: 9 February 2025
Accepted: 9 February 2025
First Online: 11 May 2025
ETHICS APPROVAL AND CONSENT TO PARTICIPATE
: The ELEFTA study was conducted according to the protocol, International Conference on Harmonisation guidelines and the principles of the Declaration of Helsinki. Before included in the study, all patients provided written informed consent. The trial protocol, protocol amendments, as well as Patient Information Sheet and Informed Consent Form were approved by Independent Ethics Council under the Ministry of Health of the Russian Federation (2022/03/01, no. 303) and by the Ethics Committee in each study center before the study initiation.
: The study was sponsored by JSC BIOCAD. The sponsor participated in the development of the study project, study program support, and the decision to submit the article for publication. The conflict of interest did not affect the results of the study. Authors A.V. Zinkina-Orikhan, Yu.N. Linkova, P.S. Pukhtinskaya, M.A. Morozova, G.A. Vinderskaya are employees of JSC BIOCAD.