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ClinicalTrials.gov ID: NCT03040622 Unique Protocol ID: 162583 Official Title: The Evaluation of Thrombogenecity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure (TARGETWATCHMAN) Trial Brief

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Efficacy refers to the ability of a product to produce a desired effect under ideal conditions, while safety refers to the absence of harmful effects when the product is used as intended.

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Filing efficacy and safety data generally involves compiling clinical trial results, safety assessments, and compliance with regulatory guidelines, and submitting the relevant documentation to the appropriate regulatory body.

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Information that must be reported includes clinical trial results, side effects, dosage, demographics of study participants, and any adverse events associated with the product.

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