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General Symptoms Some patients may report headache, fatigue, flushing, dizziness, nausea, stomach discomfort or changes in how they feel during treatment

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Data were analyzed using GraphPad Prism 8.0 software and presented as mean standard error of the mean (S.E.M.)

Theres a reason why regulations exist, and in healthcare its most often about adjudicating risk:benefit, decided by smart-but-boring-work by people with a lot of domain knowledge who can interpret it properly