2.5 Safety Assessments
Safety was assessed by monitoring adverse events (AEs) throughout the studies. Other safety monitoring included 12‐lead ECG recordings, measurement of vital signs, physical and neurological examinations, haematology, biochemistry and urinalysis. To minimise risks in the SAD and multiple ascending dose (MAD) studies, subjects were dosed sequentially using sentinels in each cohort (1 IP, 1 placebo) as per EMA guidelines.14 If the previous dose was well tolerated, with no safety concerns, dose escalation was decided by the Safety Review Group after reviewing safety and PK data from all available cohorts. Moreover, treatment with the highest dose in the SAD study was repeated for regular ophthalmological evaluations to better characterise AEs observed in the SAD study. Regular ophthalmological assessments were also performed in the MAD study.