Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT02954458
Eligibility Criteria:
Inclusion Criteria:
1. Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.
2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.
3. Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.
Exclusion Criteria:
1\. There are no exclusion criteria for this study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02954458
Study Brief:
Protocol Section:
NCT02954458