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

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.

All subjects who complete the Phase 3 REN-007 study are eligible to participate in the Extension Study.