Enrollment will be stratified to address concerns regarding the inclusion of pediatric subjects. Enrollment will begin with adult subjects ≥ 18 years of age, until there is safety information available for review from at least three adult patients who received active therapy for 8 weeks with exposure to the maximal proposed dose of 150 mg. After review of this unblinded safety information by independent Data Safety Monitoring Officer (DMSO) we will allow pediatric patients 12-18 years of age to enroll on the protocol.