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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00106860
Eligibility Criteria:
Inclusion Criteria:
* Complete Study 04-001-01
* Able to take the medication for 9 months
* Understand and sign the Informed Consent
* Comply with all study-related procedures
* Women of child bearing potential must have a confirmed negative urine pregnancy test
* Lack of clinically significant abnormalities in health
Exclusion Criteria:
* Experienced any SAEs (serious adverse events) that were related or possibly related to study drug during participation in Study 04-001-01
* Early termination from study 04-001-01
* Any new condition that could interfere with the evaluation of the subject, interpretation of safety data, or compliance with the protocol requirements
* Experiencing AEs (adverse events) such that in the opinion of the investigator, per protocol, study drug administration or safe participation in this study would be precluded.
* Taken any disallowed medications noted in Study 04-001-01 between the completion of Study 04-001-01 and entry into this trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00106860
Study Brief:
Protocol Section:
NCT00106860