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The overall mortality was 0.43 deaths per person-year versus 0.22 deaths per person-year in LVRS versus medical therapy groups, respectively (RR 3.9

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We believe that it is reasonable to require an enhanced disclosure to the patient who may be prescribed one of these drugs that this molecule is not as well-characterized as drugs that would normally be dispensed to patients, and the patient needs to understand that there may be a higher risk profile, and they should only be taken under the care of a physician, he said