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Description

Typical cycles run 4 to 12 weeks

Assuming that the percentage of patients showing an increase in serum vitamin B12 concentration to above 179 pg/ml in both groups is 70%, means the study requires at least 304 patients (152 in each arm) for a threshold of non-inferiority of 10% and a statistical power of 60% with significance set at p 179 pg/ml: patient preference questionnaire Randomisation of patients to treatment group Visit 1 (start of treatment) Anamnesis: record whether the patient lives alone or with others, lifestyle habits, use of alcohol, whether a vegan diet is followed, whether the patient has undergone gastrectomy Symptoms: record paresthesia, asthenia, loss or reduction of appetite, sadness or change in state of mind, concomitant pharmacological treatment Physical examination: for Hunters glositis, positional and vibrational sensitivity Questionnaires: Lobo cognitive mini-exam, EuroQoL-5D Record concomitant treatment Request analyses to be performed one week before next visit: haemogram and serum vitamin B12 Therapeutic plan: patient in oral arm provision of medication

There were possibly significant increases in RBC calcium (from slightly low to slightly high) and WB magnesium (from average to slightly high), and possibly significant decreases in RBC potassium (from slightly high to average) and RBC iron (high to average)