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The study missed its primary endpoint of percent change in the 28-day seizure frequency from baseline (p=0.1537). The median percent reduction of focal onset seizures in the ganaxolone group was 21.28% compared to 10.25% with placebo during the titration and the 12-week treatment period.The safety profile of ganaxolone in this study was consistent with previously conducted studies. Overall, ganaxolone was generally safe and well tolerated with no imbalance between the ganaxolone and placebo group in the number of patients with serious adverse events reported (5% vs. 5.1%). The most common adverse events (>5%) reported at greater rates than placebo were somnolence (23.5% vs 4.5%), dizziness (19.6% vs 4.5%) and fatigue (11.7% vs 6.8%). The majority of these adverse events were rated as mild in severity. There were 44 (25%) patients on ganaxolone that discontinued the study compared to 26 (14%) patients on placebo. The most common reason for discontinuation was adverse event.The Phase 3 multi-national, double-blind, randomized, placebo-controlled study was conducted at 61 sites in the United States, Germany, Poland, Australia, Bulgaria and Russia. The study randomized 359 patients into two arms, ganaxolone 1800 mg/day (n=179) and placebo (n=180). The mean age of the study population was 41 with 63% percent of the participants being female. Mean years since epilepsy diagnosis was 24.5 years. 76% of the patients were receiving two or more concomitant AED's and 12% had been treated with Vagus Nerve Stimulator.