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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT01051193
Eligibility Criteria:
Inclusion Criteria:
* Patients who completed the double-blind treatment phase of the core study (B1301).
* A parent/legal guardian must be present and give written consent for all patients enrolled in this trial. Patients consent must be obtained using assent document according to patients age.
* Females of childbearing potential must have a negative pregnancy test at Week 8 in the core study B1301.
Exclusion Criteria:
* Patients with medical ineligibility to enter the extension, as assessed by the investigator at each site.
* Patients who participated in the core study, but did not complete it (prematurely discontinued)
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
15 Years
Study:
NCT01051193
Study Brief:
Protocol Section:
NCT01051193