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The analysis of neuron density further supports these findings, with the model group showing a marked reduction in neuron density (Figure 8C), reflecting the adverse effects of sleep deprivation on neuronal health

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Under this alternative pathway, devices that are granted an FDA Breakthrough Device designation are not evaluated in terms of the current substantial clinical improvement criterion at 419.66(c)(2) for the purposes of determining device pass-through payment status, but do need to meet the other requirements for pass-through payment status in our regulation at 419.66