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For general background on how investigational peptides are evaluated for safety, the National Institutes of Healths overview of how experimental compounds move through clinical evaluation illustrates why oversight matters at every stage

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Factors such as your baseline weight, activity level, nutrition, and metabolism all play a role in your outcomes

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These two things combined less vitamin B12 transferred to the baby during gestation and via breast milk put the baby at risk for a vitamin B12 deficiency