- Any serious and unstable somatic illness (e.g. malignant tumor, severe cardiovascular disease, etc.) that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect study medication. If relevant medical findings are obtained during the examination, it is at the physician's discretion to initiate additional examinations (e.g. lab testing, ECG). If medically indicated examinations have already been carried out, the results should not be older than two weeks at the time of the screening visit. The patient can only participate in the study if all study results are within the normal range or the examiner has determined a deviation as clinically irrelevant. This should be clearly documented in the CRF.