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For example, individuals with gastrointestinal issues may find injections more beneficial, as they ensure the vitamin bypasses the digestive system entirely

Mention severe nausea, vomiting, dehydration, fainting, repeated low blood sugar, allergic reactions, or mood changes after past treatments

Pesaresi M, Maschi O, Giatti S, Garcia-Segura LM, Caruso D, Melcangi RC

Removal from Category 2 does not automatically grant Category 1 status

FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data