The mix of the two has zero controlled trials
(4) Lin N, Erdos T, Louie C, Desai R, Lin N, Ayzenberg G, Venketaraman V
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)
[112] Furthermore, this assay requires overnight incubation and may give false results if any inactive vitamin B 12 analogues are present in the foods