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Refrigeration slows degradation and helps preserve concentration consistency over the usable window

Short room-temperature windows (for example during travel) are usually fine, but refrigerate again as soon as possible

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Participants with normal hepatic function were eligible for inclusion if they were judged to be of general good health by the investigator, based on a medical examination (including physical examination, medical history, vital signs and ECG) and had liver enzyme levels within prespecified limits (alanine aminotransferase upper limit of normal [ULN] + 10%, aspartate aminotransferase ULN + 20% and total bilirubin ULN + 20%)

Doses in preclinical studies have typically ranged from 10 nanograms to 10 micrograms per kilogram of body weight, administered daily

The device is determined to be reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body part, as required by section 1862(a)(1)(A) of the Act