BDZ - I understand that more robust trials will be necessary to confirm the results of the CKD and Cognition sub-studies. However, I’m unclear as to the need for one on CVD. BoM focused on 3 pt. MACE that included stroke with ABL having demonstrated no impact on stroke. When substituting CHF for stroke the BoM trial would have achieved statistical significance.
So, why do another trial that would substitute stroke with CHF when we already know the result? Further, when planning another CVD trial, whether it’s called a bolt-on or something else, what would that trial (in your opinion) look like?
Apologies in advance for my scientific ignorance.....and thanks.