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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT01670669
Eligibility Criteria:
Inclusion Criteria:
* Subject completed the PRU-USA-12 pharmacokinetic trial
* Subject bowels had been "cleaned-out" (ie, any faecal impactions removed)
* Written informed consent, signed by the subject's legal guardian and by the investigator
* Subject assent documented in the form of a note-to-file in the subject's source documentation
Exclusion Criteria:
• No exclusion criteria
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT01670669
Study Brief:
Protocol Section:
NCT01670669