This side effect was generally described as mild and was first identified in the Phase II program
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Antioxid Redox Signal (2015) 22(5):398410
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The 510(k) procedure is also applicable to certain class I devices that are not 510(k)-exempt, as well as a small number of class III devices
This route carries a higher risk of certain side effects: 5,7,8 Allergic reactions: Hives, swelling, difficulty breathing, or severe skin reactions (e.g., Stevens-Johnson syndrome)