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The FDA has not issued formal reclassification guidance

However, the signal-to-noise from 13C-MRS is such that human studies generally require very large regions of interest and long acquisitions (over half of the frontal lobe for 120 min [139], contrasted with 5 to 10 min for single voxel 1 H-MRS and 17 min for EPSI)

I am going to provide you with six examples so you can choose what works best for you based on your preference, equipment availability, tolerance, function, etc

However, this was not a controlled trial there was no placebo group, and the assessments were informal (patient surveys by phone)

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Science 351 , aaa5694 (2016)