Ethical conduct of the study
The study proceeded in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. The trial protocol was reviewed and approved by the Independent Ethics Committees of the involved sites and the Ethics Council of the Ministry of Health of the Russian Federation. The study design and methodology have been developed in line with the FDA [To be included, participants needed to be able to understand the content of the informed consent documents and be willing to sign the informed consent form. Written informed consent was obtained from each participant before eligibility screening.