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Per the applicant, patients in the hospital for their initial TECVAYLI TM treatment will receive three doses subcutaneously—a 0.06 mg/kg loading dose, a 0.30 mg/kg loading dose, and the first 1.5 mg/kg treatment dose—during the hospital stay
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More recent trials have used increasingly stringent endpoints for clinical remission, which includes the necessity for the rectal bleeding subscore of the Mayo score to be zero, and definitions of corticosteroid‐free remission differed, with some RCTs mandating a minimum duration that corticosteroids had to be discontinued for