revocation of informed consent by the patient. patient mismatch inclusion criteria. first identified conditions and / or diseases described in the non-inclusion criteria. the criteria for early termination of patient participation in the study during the period of use of the study drug are: patient withdrawal of informed consent. first identified conditions and / or diseases described in the non-inclusion criteria. the occurrence of serious adverse events. adverse events that do not meet the criteria of severity, the development of which, according to the researcher, further participation in the study may be detrimental to the health or well-being of the patient. administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as gross protocol violations that may affect the results of the study. the patient receives / needs additional treatment that may affect the outcome of the study or patient safety individual intolerance to research drugs incorrect inclusion (for example, the patient was included in violation of the criteria for inclusion / non-inclusion of the protocol)

revocation of informed consent by the patient. patient mismatch inclusion criteria. first identified conditions and / or diseases described in the non-inclusion criteria. the criteria for early termination of patient participation in the study during the period of use of the study drug are: patient withdrawal of informed consent. first identified conditions and / or diseases described in the non-inclusion criteria. the occurrence of serious adverse events. adverse events that do not meet the criteria of severity, the development of which, according to the researcher, further participation in the study may be detrimental to the health or well-being of the patient. administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as gross protocol violations that may affect the results of the study. the patient receives / needs additional treatment that may affect the outcome of the study or patient safety individual intolerance to research drugs incorrect inclusion (for example, the patient was included in violation of the criteria for inclusion / non-inclusion of the protocol)

1. revocation of informed consent by the patient. 2. patient mismatch inclusion criteria. 3. first identified conditions and / or diseases described in the non-inclusion criteria. the criteria for early termination of patient participation in the study during the period of use of the study drug are: 1. patient withdrawal of informed consent. 2. first identified conditions and / or diseases described in the non-inclusion criteria. 3. the occurrence of serious adverse events. 4. adverse events that do not meet the criteria of severity, the development of which, according to the researcher, further participation in the study may be detrimental to the health or well-being of the patient. 5. administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as gross protocol violations that may affect the results of the study. 6. the patient receives / needs additional treatment that may affect the outcome of the study or patient safety 7. individual intolerance to research drugs 8. incorrect inclusion (for example, the patient was included in violation of the criteria for inclusion / non-inclusion of the protocol)

1. revocation of informed consent by the patient. 2. patient mismatch inclusion criteria. 3. first identified conditions and / or diseases described in the non-inclusion criteria. the criteria for early termination of patient participation in the study during the period of use of the study drug are: 1. patient withdrawal of informed consent. 2. first identified conditions and / or diseases described in the non-inclusion criteria. 3. the occurrence of serious adverse events. 4. adverse events that do not meet the criteria of severity, the development of which, according to the researcher, further participation in the study may be detrimental to the health or well-being of the patient. 5. administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as gross protocol violations that may affect the results of the study. 6. the patient receives / needs additional treatment that may affect the outcome of the study or patient safety 7. individual intolerance to research drugs 8. incorrect inclusion (for example, the patient was included in violation of the criteria for inclusion / non-inclusion of the protocol)