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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01034267
Eligibility Criteria:
Inclusion Criteria:
* Completed 1 of the lead-in studies LVM-MD-01, LVM-MD-02, or LVM-MD-03
* Have normal examination findings at the final visit of the lead-in study
* Have a negative serum pregnancy test at the final visit of the lead-in study if a woman of child-bearing potential
Exclusion Criteria:
* Any exclusionary psychiatric or medical condition that developed during the lead in study
* Patients considered a suicide risk
* Women who are pregnant, breastfeeding, or planning to become during the study OR are sexually active and not currently using a medically acceptable method of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01034267
Study Brief:
Protocol Section:
NCT01034267