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Disrupted sleep (occasional MOTS-c report at higher doses)

The risk of severe GI events is increased by the presence of the following factors: history of peptic ulcer disease or GI bleed, smoking, alcohol usage, concomitant usage of anticoagulants, or oral corticosteroids, older age, and poor general health status

In the United States, a drug development company must file for Investigational New Drug (IND) status before a FIH trial can begin, often preceded by a pre-IND meeting with the FDA