by no means an expert, however, the difference between an implantable device (and being a replacement heart valve, and therefore vital for survival) and a drug that can be stopped is one factor that may drive the amount of evidence required, and, having a performance level to be achieved (XX% better improvement), there will likely be a complicated calculation that will determine the necessary sample size for the trial.
Just a relatively uneducated opinion - not advice.
by no means an expert, however, the difference between an...
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