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:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT00112203
Eligibility Criteria:
Inclusion Criteria:
* Patients must have completed the 8 week double-blind study ITOFD04-03
* Female patients must not be pregnant (must have a negative serum pregnancy test)
Exclusion Criteria:
* Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-03 study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00112203
Study Brief:
Protocol Section:
NCT00112203