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All SAEs of death, development of signs of critical illness and severe illness requiring hospitalisation, and AEs as described previously will be reported to the Ethics Committees, the Data and Safety Monitoring Board (DSMB) and to the sponsors of the study within 24 hours of awareness of the event, followed by a final report within 10 days

Pyridoxine is categorized as pregnancy category A, meaning controlled studies have shown no risk to the fetus

Vitamin B12 deficiencies are therefore quite common among vegetarians and vegans

However, for B12, if any part of that complex digestive process is compromised especially the intrinsic factor or the absorption sites in the intestine then a significant portion of the B12 from a tablet might never reach your bloodstream

Contraindications include known hypersensitivity to any component of the injection (including cobalt hypersensitivity), a history of severe reactions to thiamine/pyridoxine/cobalamin injections, and Lebers hereditary optic neuropathy (for B12-containing products)

These advanced protocols require careful planning to manage injection frequency, timing, and potential interactions