Inclusion Criteria:  Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008 Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study  Exclusion Criteria:  Inability to provide consent An adverse event during Study SPM-008 which precludes participation in this study Any condition per the investigator's clinical judgement that precludes participation in the study