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We clarify that we were referencing 42 CFR 410.26 in the language incident to or integral to used in the proposed rule and that for clarity we are using incident to by itself in this section regarding DMHT devices furnished incident to professional behavioral health services used in conjunction with ongoing behavioral health treatment under a behavioral health treatment plan of care

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Based on preclinical (animal and cellular) data only, inhibition of NNMT by 5-Amino-1MQ is theorised to: Raise intracellular NAD+ levels Activate SIRT1 and other sirtuins (proteins linked to metabolic regulation) Reduce fat cell (adipocyte) size and proliferation Improve insulin sensitivity These effects have been demonstrated in mouse models (Neelakantan et al., 2019), but robust human clinical trial data are currently absent

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