ABO-treated subjects reported feeling better/much better about themselves at week 4 (>75%), week 24 (>61%), and week 36 (>39%). Irrespective of ABO dose, most subjects (>91%) wanted to receive the same treatment again at week 36 and indicated that they would recommend the treatment to family/friends.
Safety Endpoints
Overall, 87 TEAEs were reported by 61 ABO-treated subjects. Ten individuals receiving placebo reported 14 TEAEs during the study. Fifteen TEAEs, reported by 13 (4%) ABO-treated subjects and one (1.3%) placebo group participant were related to treatment (Table 2). Most treatment-related TEAEs (80%) were mild, with the remainder being of moderate severity. With the exception of one event (mild dry eye), all treatmentrelated TEAEs resolved during the study. The most common ABO-related TEAEs were mild headache (1.2%) and eyelid ptosis (1.2%). One subject had mild ptosis in each of the 75 U and 125 U groups, and two subjects had moderate ptosis in the 100 U group (Table 2). All ptosis cases occurred during the first 16 days posttreatment, and all events resolved (median duration: 75 days). No treatment-related TEAEs were reported to be serious and none resulted in premature study discontinuation. There were no incidents of seroconversion to ABO neutralizing antibodies during the study.
