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Signs that warrant urgent medical evaluation include dry mucous membranes, orthostatic lightheadedness, urine output below 500 mL in 24 hours, and heart rate persistently above 100 bpm 17

While voting yes, Christopher Lieu, committee chairperson and director of the Gastrointestinal Medical Oncology Program at the University of Colorado, acknowledged that a positive decision could lead to a slippery slope in terms of the degree of clinical evidence that will be required of future drug applications in similar rare and difficult-to-study indications