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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00819234
Eligibility Criteria:
Inclusion Criteria:
* Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations
* Male, or female and meets all the following criteria:
1. Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)
2. If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
* Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements
Exclusion Criteria:
* Is expected to require or undergo treatment with any exclusionary medication.
* Is undesirable as a study participant as judged by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00819234
Study Brief:
Protocol Section:
NCT00819234