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If we do a label expansion, in other words, if we have a device on the market now as a prescriptive device, and then we essentially want to take the hcp, the healthcare professional, out of the loop and make it over the counter, that's a label expansion that usually will require additional testing, usually in these additional intended use environments

How To Use: As a dietary supplement, take three (3) capsules once a day with food or water

However, this does not strictly apply to growth with CM, as formaldehyde is not a direct product of CM dehalogenation by the cmu pathway (Vannelli et al., 1999