Adverse events
Twenty-two subjects had at least one AE: 17 (30%) in the intervention arm and 5 (19%) in the control arm. Overall, 35 AEs were reported: 30 (85.7%) in the interventon arm and 5 (14.3%) in the control arm. Ten of these AEs were attributed to investigations [i.e., laboratory parameters: eight (80.0%) in the intervention arm and two (20.0%) in the control arm]. Details are listed in 