This is a long-term study. People who were in two previous studies, called INSPIRE 1 and INSPIRE 2, will continue in this new study called INSPIRE LTE. It is an open-label study, meaning everyone knows what treatment they are getting.
Who Can Join? To be in the study, you need to understand what the study is about, sign a form saying you agree to the study, and follow study rules. You must have already been in the earlier studies and completed those without any problems.Who Cannot Join? If you are a woman who can have children, you need to agree to use birth control. If you are pregnant or breastfeeding, you cannot join. If you have any health issues that might make the study unsafe for you, you also cannot join.
- **Duration:** Long-term study following earlier test phases.
- **Participation:** Must have been in previous studies.
- **Safety:** Not for pregnant or breastfeeding women.