Outcomes of treatment effectiveness | |
 | Time to treatment response or onset of action (based upon patient or expert/observer reported response assessment) |
Duration of action or sustainability of response | |
Patient reported improvement at 30Â days, and between 112 and 120Â days, or nearest approximations | |
Expert/observer reported improvement at 30Â days, and between 112 and 120Â days, or nearest approximations | |
Changes in quality of life (assessed using validated instruments) | |
Detection of neutralizing antibodies | |
Short-term unintended effects of treatment or treatment delivery (harms) | |
 | Injection site pain or hyperesthesia, edema, ecchymosis or cutaneous infections |
Urticaria | |
Anaphylaxis | |
Use of botulinum anti-toxin | |
Headaches | |
Flu-like malaise | |
Longer-term unintended effects of treatment (harms) | |
 | Functional neurologic deficits or disfigurements (for example brow or lid ptosis, blepharoptosis, ectropion or entropion) |
 | Strabismus and diplopia |