Inclusion Criteria:  1. Subject must have completed the AVRO-RD-01-201 study.  Exclusion Criteria:  1. Subject has any medical, psychological, or other condition that, in the opinion of the Investigator: Might interfere with the subject's participation in the study (including consenting to procedures); and/or Poses any additional risk to the subject; and/or Might confound the results of any study-required assessments.