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In the TIL/ACT group the autologous TIL were isolated from resectedmetastatic melanoma lesions that were grown in vitro for 14 days with anti-CD3 antibody andIL-2 before patient infusion. This stepincludes a descriptive characterization of the nature,severity, and route dependency of any potential healtheffects, as well as variation within the population(s)of concern.

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This isessentially the classical categorization for auditory dis-orders, but it can also be applied to visual and chemo-sensory disorders (Table 17.2).

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