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Human clinical evidence is insufficient to confirm therapeutic benefit

Extremes matter: patients under 50 kg often do well at the lower end, patients over 100 kg may sit at the upper end of standard ranges

Rigorous human studies are required to determine safety parameters, mechanistic specificity, and potential translational relevance before any clinical applications can be considered

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"The most important thing to take away is that your voice matters, because this committee is just issuing a recommendation to the FDA

First of all, GSSG may activate the SAPK/MAPK pathway, leading to cell apoptosis