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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT01395992
Eligibility Criteria:
Inclusion criteria:
* Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment
* Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691
Exclusion criteria:
* A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subject's continuation into this long-term extension trial
* A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691
* A participant must not be at imminent risk of self-harm or harm to others
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01395992
Study Brief:
Protocol Section:
NCT01395992