Endpoints and assessments
DLTs
Primary objective was safety of FLYSYN monotherapy at various dose levels. Primary endpoint was incidence and severity of AEs over 28 days (i.e., Visit 7, day 29) in cohorts 1–5 and over 35 days after last dosing (i.e., Visit 9a, day 64) in cohort 6. Secondary safety endpoint was incidence and severity of AEs until day 180 days (Visit 11) after first dosing. DLTs (detailed description in Additional file 