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
Understanding Melanin Melanin is the pigment responsible for the color of your hair, eyes, and skin
Do not inject into the same anatomical region until the reaction has completely resolved
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