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Before inclusion 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 (September 21, 2022, no. 562) and by the Ethics Committee in each study center before the study initiation.","order":1,"name":"Ethics","label":"ETHICS APPROVAL AND CONSENT TO PARTICIPATE","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"The study was sponsored by JSC BIOCAD. Authors A.V. Zinkina-Orikhan, Yu.N. Linkova, A.A. Lutckii, P.S.\u00a0\u00a0Pukhtinskaya, E.A. Fokina, A.A. Porozova, and A.V.\u00a0Eremeeva are employees of 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.","order":2,"name":"Ethics","label":"CONFLICT OF INTEREST","group":{"name":"EthicsHeading","label":"Ethics"}}]}}