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That rationale must be backed by non-clinical data confirming the compound behaves as expected and by a thorough safety and toxicology program that identifies potential risks and establishes a safe starting dose for the first human administration and the maximum human exposure that should not be surpassed
Trayhurn P (2013) Hypoxia and adipose tissue function and dysfunction in obesity
The reporting frequency depends on the patients clinical condition and the physicians medical judgment
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