Overview
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery:
- Patient reported outcomes (PRO), using the EQ-5D questionnaire
- Clinical outcomes
Eligibility
Inclusion Criteria:
- Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.
Exclusion Criteria:
- Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study.
- Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.