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PMID 3257264

Keep track of any new or worsening symptoms, particularly gastrointestinal disturbances, signs of hypoglycaemia (especially if taking insulin or sulfonylureas), or neurological symptoms

However, certain conditions, such as digestive disorders, can interfere with the absorption of B12

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