- Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: hours, days, months; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: 72 hours after having given every dose of therapy and at weeks 15, 18, 22, 27, 33, 36 and 40. - Certain hematologic (hemoglobin, hematocrit, white blood cell count with differential, ESR, platelet count). Measuring time: weeks 0, 3, 7, 15, 20, 27 and 40. - Biochemical (pyruvic transaminase blood levels, oxaloacetic transaminase, alkaline phosphatase, uric acid, urea, creatinine, prothrombin time, protein in urine, bilirubin, glucose, cholesterol, triglycerides). Measuring time: weeks 0, 3, 7, 15, 20, 27 and 40. - Vital signs (temperature, blood pressure). Measuring time: weeks 0, 1, 2, 4, 8, 12, 15, 18, ??22, 27, 33, 36 and 40.