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Finally, the applicant stated that, under the regulation at 419.66(a), CMS makes a pass-through payment for a medical device that meets the requirements in paragraph (b) of that section and that is described by a category of devices established by CMS under the criteria in paragraph (c) of that section, and that, further, according to 419.66(g), the pass-through period begins on the first date on which pass-through payment is made

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In the normal renal function group, one participant had a clinically significant vital sign abnormality (increased blood pressure) and one had a clinically significant ECG abnormality, with both reported as resolved mild TEAEs

The evolutionary trade-off: a word of caution A critical consideration in senotherapy is the evolutionary role of cellular senescence 131

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