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After consideration of the public comment we received and our review of the application, we agree with the applicant and have determined that the SCOUT MD TM Delivery System meets the eligibility criterion at 419.66(b)(3)

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The use of supplements such as MCT, electrolytes, amino acid like leucine and lysine and exogenous ketones have been suggested to aid in the induction of ketosis, and may possibly shorten the window and/or lessen the burden of symptoms