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CMS had defined a patient-reported outcome (PRO) as any report of the status of a patient's health condition or health behavior coming directly from the patient without interpretation of the patient's response by a clinician or anyone else

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(3) For purposes of paragraph (b)(1) of this section, the percentage of time the drug is currently in shortage during the applicable period is equal to the number of days such drug is currently in shortage in an applicable period, divided by the total number of days in the applicable period

For example, characterising flavours other than tobacco have been banned in cigarettes, but not in (most) other tobacco and nicotine products, in Europe, Canada and the USA.19 75 While adults may use ENDS to quit or reduce smoking,73 76 77 adolescents and young adults often mention novelty and curiosity.7678 Flavours, in particular, attract both youth and adults to use ENDS79 80