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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT03039634
Eligibility Criteria:
Inclusion Criteria:
* Subject has participated in study 755.1100\_FA, 810.1100\_FA, or 1064.1100\_FA and fulfilled that study's exit criteria (ie, completion of the final visit \[visit 7\] of that study).
* Subject has followed predecessor study restrictions prior to study entry.
* Subject is able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA); minors will in addition have parent or legal guardian provide consent.
* Subject is willing to comply with the schedule, procedures, and restrictions of the study.
Exclusion Criteria:
* Subjects who have had any treatments or conditions (eg, pregnancy or metabolic disease) that may affect assessment of the safety or efficacy since enrollment in the predecessor study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03039634
Study Brief:
Protocol Section:
NCT03039634