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PKA, in turn, inhibits the opening of adenosine triphosphate (ATP)-sensitive potassium channels (KATP) on the cell membrane (49), inhibits potassium efflux and promotes the opening of L-type voltage-dependent calcium channels (VDCs) (50), facilitating the release of calcium ions

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The standard justification requires a documented medical need, such as a verified allergy to an inactive ingredient in the brand-name formulation, that makes the FDA-approved version unsuitable for that specific patient