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[24] [25] For patients with confirmed pathological hypercortisolism (Cushing's syndrome), definitive treatment depends on etiology and may include transsphenoidal surgery for pituitary adenomas, adrenalectomy for adrenal tumors, or medical therapy

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The panel cited the high rate of acute kidney injury (AKI) in patients assigned to the treatment group, which it said could potentially be attributed to ITCA 650

The amount of mannitol in a pharmaceutical formulation, eg, a pharmaceutical formulation that does not contain tris base, can be about 87.9 mg, about 125.3 mg or about 130.9 mg