I will comment and then pass it to Dr. Stewart.
We acknowledge that clinical trials have restrictions and may not reflect what happens once a drug goes into what we call real-world use. That is one of the reasons we have a conditional approval system for some of these products, where we can issue an approval of a medication on promising evidence from clinical trials, but with a commitment from the manufacturer that they are going to confirm that benefit and that safety profile once the product goes into use. That can be with confirmatory trials, registries, monitoring what happens in the actual usage and so on.
Dr. Stewart may want to add something to my answer.