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In order to evaluate substantial clinical improvement over currently available treatments to meet the transitional pass-through payment criterion at 419.66(c)(2), we stated that we consider supporting evidence, preferably published peer-reviewed clinical trials, that demonstrates improved clinical outcomes, such as reduction in mortality, complications, subsequent interventions, future hospitalizations, recovery time, pain, or a more rapid beneficial resolution of the disease process comparing the nominated device to the standard of care (88 FR 81733)

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Benson C, Mifflin K, Kerr B, Jesudasan SJ, Dursun S, Baker G.Biogenic Amines and the Amino Acids GABA and Glutamate: Relationships withPain and Depression

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