Adverse Events (AEs) defined as <i>certainly, probably</i> or <i>possibly</i> related to the study medication.

an = number of subjects reporting the events; b N = number of evaluable subjects (%); c Severity grade: 1 = mild, 2 = moderate, 3 = severe. All the study participants prior to the protocol amendment (n = 87) have been evaluated for safety. The Medical Dictionary for Regulatory Activities (MedDRA) was used to classify the adverse events occurred during the study.