Joanne Foody
Analyst · Goldman Sachs. Your line is open.
Paul, thank you so much for your question. I think obviously, it’s top of mind, has COVID impacted the study? Just you know, I’ll give you some thoughts on that. So first of all, remember that the entire trial was enrolled well before COVID in 2019. We’ve worked tirelessly throughout the study working with our CRO, our ARO, and multiple vendors to ensure the integrity of the trial and really minimize impact from COVID. We’ve been working with regulators as well tracking that throughout the study, and in fact, that study has been identified, if you will, as a best practice for how unfortunately to conduct a large cardiovascular outcome trial during COVID. In general, yes, there are individuals that have COVID within the study, the events have not been significantly changed in either type or proportion, relative to COVID and that grid gives us really great confidence. The study had been running, to all our surprise, but due to a lot of hard work, as we would have anticipated the study to run prior to COVID. So the events are tracking as we would have anticipated, as you can see, with the accumulation of 90%. They’re not overly enriched by COVID-related events and again, we’re looking for a successful close out of the study and hope that this really becomes, again, a best practice of how to engage patients, keep these patients in trials through multiple challenges. Remember that the randomization, right, 14,000 patients randomized really also gives us great certainty and confidence that COVID would affect both sides of the equation and would not impact the study of this size scale or scope.