The primary objective is to provide continued access to subjects who would like to continue an active drug intestinal gel , after completion of an open-label study (S187.3.003 or S187.3.004).
From 30 Years to 99 Years.
- The participant should have completed participation in Study S187.3.003 or S187.3.004;
and, in the opinion of the Principal Investigator, would benefit from long-term
treatment with LCIG.
- For Canada, participants will be allowed to participate in the S187.3.005 study with a
minimum of 6 months of exposure to LCIG in the S187.3.004 study.
- The participant must be able to understand the nature of the study and must provide
written informed consent prior to the conduct of any study related procedures. If the
participant does not have the capacity to provide informed consent, full informed
consent must be obtained from the participant's legally authorized representative.
Consenting will be performed according to local regulations.
- Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be
clinically significant and which could interfere with the participant's participation
in the study.