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episodes have included one or more of the following features: anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, laryngeal edema, face edema, peripheral edema, laryngospasm, maculopapular rash, and vesiculobullous rash (vesicular rash, bullous rash)

There is a randomized, placebo-controlled trial on the finished product in healthy adults (not the same as proving each ingredient individually)

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[4] Ferguson, G