For people ages 4 years and up
OLE Period Key Inclusion Criteria:
- Successful completion of clinical study C601
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
OLE Period Key Exclusion Criteria:
- Positive urine pregnancy test (in females of child-bearing potential) or females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
- Any new disease, condition, or circumstance which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol (e.g., an anticipated change of care setting)
RW Period Key Inclusion Criteria:
- Provide voluntary, written informed consent (parent[s] / legal guardian[s] of participant); provide voluntary, written assent (participants, as appropriate); this includes consent for randomization and potential treatment with placebo for up to 16 weeks
- Currently participating in clinical study C602 and complete the OLE End of Treatment Visit procedures
RW Period Key Exclusion Criteria:
- Positive urine pregnancy test (in females of child-bearing potential)
- Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation