5.3. Treatment-Relationship of DaxibotulinumtoxinA and RTP004 Immunogenicity
Treatment-related
Treatment-related antibody responses included both treatment-induced (negative at baseline and at least 1 antibody positive result post-treatment) or treatment-boosted (positive at baseline with an increase in antibody titer post-treatment to at least 4 times the baseline value). Subjects with a positive antibody result at baseline and no increase in titer during the treatment follow-up were classified as treatment-unaffected. The baseline binding antibody assessments prior to the first DAXI or placebo treatment in SAKURA 1 and SAKURA 2 were the baseline values for determining treatment-induced or treatment-boosted antibody status, including those for subjects who rolled over to SAKURA 3. The baseline for newly enrolled subjects in SAKURA 3 was the screening visit. 