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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
This might mean that a protocol calls for splitting a total daily dose into two smaller administrations to maintain more stable levels
