A new interim analysis at 80% of the number of final-analysis events has been added (in addition to the pre-existing interim analysis at 60% of final events), and AMRN has an SPA for the changed protocol.
The new p-value thresholds for statistical significance are: 0.0076 at the 60% interim (results expected in next two months); 0.022 at the 80% interim (results expected in mid 2017); and 0.0422 at the final analysis (results expected in 2018).
The SPA also includes several new secondary endpoints.