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November 29, 2022

Risk vs. the benefits that accompany clinical utilization of the product based on substantial clinical evidence of safety and effectiveness for the products approved indication(s) for use

Risk vs. the benefits that accompany clinical utilization of the product based on substantial clinical evidence of safety and effectiveness for the products approved indication(s) for use? Are the promotional materials misleading? If so, how can the material be (re) written or otherwise modified to present a more balanced overview to consumers about the benefits associated with using the product?

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