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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT00476034
Eligibility Criteria:
Inclusion Criteria:
* Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation.
Exclusion Criteria:
* Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician
* Those patients who were non-compliant or who demonstrated a major protocol violation in the core study.
Other protocol-defined inclusion/exclusion criteria may apply
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00476034
Study Brief:
Protocol Section:
NCT00476034