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321(g)(1), any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans qualifies as a drugand drugs require premarket approval through the New Drug Application (NDA) process before lawful distribution

When designing mix protocols, researchers should consider possible interactions, adjust doses appropriately (may use lower doses of each when combined), use enhanced safety tracking, and include appropriate control groups

Hoshida S

The serum LC and ALC concentrations of all the individuals in the HC and MDD groups were compared with an independent-sample t -test and the serum LC and ALC concentrations of MDD before and after treatment were compared with a paired-sample t -test