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Each summary identifies the experimental model used

While the risk at therapeutic doses remains low, reduced liver synthetic function or impaired metabolic pathways may warrant closer monitoring and dose adjustment

The second criterion for establishing a device category, at 419.66(c)(2), provides that CMS determines either of the following: (1) that a device to be included in the category has demonstrated that it will substantially improve the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body part compared to the benefits of a device or devices in a previously established category or other available treatment

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HGF was incubated without (control) or with various drug candidates at 10 "10 M