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Statements regarding outcomes are not guarantees and have not been evaluated by the FDA

Comment: Several commenters were concerned that implementing the proposed attestation statement would overwhelm the file with conditional logic and supporting documentation that cannot conform to the file schema and would undermine the goal of machine-readability and comparability

Comment: Commenters indicated that the proposed data collection on Worksheet S-12 would be administratively burdensome and that it was often unclear how the hospital should perform the required calculations

Fatigue and Low Energy: Provides an energy boost for those with chronic fatigue