Overall safety
A higher proportion of subjects reported IMP-related AEs with 12 SQ-Bet
than with placebo (Table 2). IMP-related AEs were mainly local allergic
reactions primarily in the oral cavity and throat and were related to
the sublingual administration of IMP. They were mild or moderate in
severity: 79% were mild and 17% moderate with 12 SQ-Bet and 65% were
mild and 31% moderate with placebo. The majority resolved without
treatment (76% of events for 12 SQ Bet and 83% for placebo).