“However, the success or failure of the trial will depend upon the statistical result of the primary outcome on the combined statin group. If this fails to achieve statistical significance, then the pre-specified subgroup analyses of the primary outcome may be invalid”

If the Crestor/Apabetalone results reach statistical significance, it will be valid regardless of the Lipitor/Apabetalone results. These are two different treatment arms.

The issue would be whether the FDA would require a further larger study using Crestor/Apabetalone alone to replicate results.

While Lipitor/Apabetalone results were not as good on plaque regression, overall MACE results were strong with both statins so I don’t think we will see this outcome.

bfw