Eighty-seven participants were included in the safety set analysis (mean age, 22.6 ± 6.9 years). At Baseline almost all participants had a medical or surgical history (99%), of which the most common were: seizures (93%), constipation (56%), sleep disorder (44%), gastroesophageal reflux disease (28%), scoliosis (26%), anxiety (25%), tremor (18%), strabismus (17%), and seasonal allergy (17%). The majority of participants reported the use of concomitant medications (98%), of which the most common were: benzodiazepine derivatives (66%), including clonazepam (34%), diazepam (17%), lorazepam (13%), and clobazam (12%), used in the treatment of seizures. This was followed by other anti-epileptics (45%), including lamotrigine (20%), levetiracitam (18%), topiramate (18%), brivaracetam (13%) and valproic acid (10%). Other common prescription and over the counter medications included: melatonin (31%), polyethylene glycol (26%), ibuprofen (21%), vitamin supplements (17%), paracetamol (15%), omeprazole (15%), clonidine (14%), trazodone (10%), and ondansetron (10%).