 The study will consist of 4 clinic visits, including ScreeningBaseline Visit 1 Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator. 