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Regulatory agencies require extensive clinical evidence before approval, and the absence of such data means safety and effectiveness remain uncertain

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(2015): in studies of drugs approved between 2010 and 2012, just 45 percent of trial participants in small molecule trials were women, but they represented 65 percent of participants in biologic trials (based on Drugs@FDA data)

Given the peptide's short plasma half-life (~0.51 hour), daily dosing maintains more consistent exposure to the peptide's gene-expression-modulating effects

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