Serious AEs
No deaths were reported in the pooled phase-II/III trials. 15 subjects
(2%) experienced 15 SAEs, 9 of these were reported with 12 SQ-Bet and 6
with placebo. 2 SAEs were assessed as IMP-related: 1 in each of the two
groups, both involving accidental intake of IMP by subject’s child. Both
cases were asymptomatic as has previously been
described13.