Inclusion Criteria:  Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3.  Exclusion Criteria:  Received prohibited medication in the Parent study, CLS1002-101. Enrolled in the Parent study CLS1002-101 as part of Cohort 1. Females of childbearing potential who are pregnant and or lactating.