1. erroneous inclusion (violation of inclusion/non-inclusion criteria). 2. individual intolerance to the investigational drug. 3. refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient. 4. termination of the study.

1. erroneous inclusion (violation of inclusion/non-inclusion criteria). 2. individual intolerance to the investigational drug. 3. refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient. 4. termination of the study.

erroneous inclusion (violation of inclusion/non-inclusion criteria). individual intolerance to the investigational drug. refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient. termination of the study.

erroneous inclusion (violation of inclusion/non-inclusion criteria). individual intolerance to the investigational drug. refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient. termination of the study.

1. erroneous inclusion (violation of inclusion/non-inclusion criteria). 2. individual intolerance to the investigational drug. 3. refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient. 4. termination of the study.

1. erroneous inclusion (violation of inclusion/non-inclusion criteria). 2. individual intolerance to the investigational drug. 3. refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient. 4. termination of the study.