- withdrawal of informed consent by a volunteer; - serious adverse events or adverse events that do not meet the criteria for severity, the development of which, in the opinion of the investigator, may be detrimental to the health or well-being of the volunteer; - the need for procedures and/or drug treatment not permitted by the study protocol; - the volunteer was included in violation of the inclusion/non-inclusion criteria of the protocol; - the emergence of non-inclusion criteria during the study; - the need for surgical intervention; - any condition in a volunteer requiring, in the reasonable opinion of the investigating physician, the withdrawal of the volunteer from the study; - the volunteer refuses to cooperate or is undisciplined (for example, not showing up for a planned visit without warning the investigator and/or losing contact with the volunteer), or has dropped out of observation; - for administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as for gross violations of the protocol that could affect the study results.

- withdrawal of informed consent by a volunteer; - serious adverse events or adverse events that do not meet the criteria for severity, the development of which, in the opinion of the investigator, may be detrimental to the health or well-being of the volunteer; - the need for procedures and/or drug treatment not permitted by the study protocol; - the volunteer was included in violation of the inclusion/non-inclusion criteria of the protocol; - the emergence of non-inclusion criteria during the study; - the need for surgical intervention; - any condition in a volunteer requiring, in the reasonable opinion of the investigating physician, the withdrawal of the volunteer from the study; - the volunteer refuses to cooperate or is undisciplined (for example, not showing up for a planned visit without warning the investigator and/or losing contact with the volunteer), or has dropped out of observation; - for administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as for gross violations of the protocol that could affect the study results.