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The CRL is specifically for part one of the New Drug Application, in which Zealand sought approval for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with CHI for up to 3 weeks of dosing

11.10%, aOR 0.52, 95% CI 0.31-0.87, p=0.01), and shorter length of stay at 7 days (3.53 2.05 vs

In celiac disease, intestinal damage induced by the autoimmune reaction to gluten ingestion manifests as a flattening of the villi (a hallmark of celiac disease), which reduces the surface area available for nutrient absorption