Key new elements reflected in the company's amendment include:
- Finalized details of the statistical analysis plan covering both final and interim efficacy analyses;
- Added a second pre-specified interim efficacy analysis at approximately 80% of the 1,612 primary cardiovascular events targeted for completion of the study; and
- Expanded to over 30 the number of pre-specified secondary and tertiary endpoints in an effort to more fully capture the broad potential clinical effects of Vascepa (icosapent ethyl) and the diversity of the patient population being studied.
