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Another relevant exclusivity period applies when a previously approved drug is approved for a new patient population based on new clinical studiesany ANDAs directed to that new patient population (NPP) may not be approved for a period of three years

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However, when it is in excess, these benefits are overcome by a pro-inflammatory activity, being associated with worse haemodynamic and metabolic profile in patients affected by HFpEF [35, 36]

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