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4.4 Special warnings and precautions for use Endpoint [Change from baseline] 55% [10%] 77% [35%] 85% [35%]

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Role of the Sponsors: The funding source had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; and preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

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Postmarketing reports: Cases of sudden decrease or loss of hearing in temporal association with the use of PDE5 inhibitors, including this drug[Ref] Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green.Renal Impairment

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