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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT02727751
Eligibility Criteria:
Inclusion Criteria:
* Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302
* Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies
* Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
* Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization
Exclusion Criteria:
* Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302
* The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02727751
Study Brief:
Protocol Section:
NCT02727751