- subject has a concomitant disease which may affect the assessment of the study results: active TB form; chronic hepatic and renal diseases; considerable impairment of thyroid function and other endocrine diseases (diabetes mellitus), severe diseases of the hematopoietic system; epilepsy and other CNS disorders; myocardial infarction in previous history; myocarditis; endocarditis; ischemic heart disease; autoimmune disorders; severe chronic diseases requiring follow-up at the hospital; and, other diseases that, in opinion of the Investigator, will not allow a subject to take part in the study or may affect the study course and/or its results (e.g. assessment of the safety parameters);