Safety assessment will comprise continuous adverse event reporting, regular physical examinations and regular assessments of vital signs, haematology, blood chemistry and urine. A 12-lead ECG will be performed at screening and at the end of the study. Pregnancy testing will be performed according to applicable legislation in the country where the trial is being performed. At the very least, women of childbearing potential must undergo a pregnancy test during screening for the study, before the first dose and at the end of the study.