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both low (median 6.4%) and high (median 10.5%) HbA1c were associated with higher mortality compared with 7.5% [218]
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The secondary outcomes will be the serum vitamin B12 concentration (pg/ml), adverse events (description, moment of onset and resolution, intensity, cause, steps taken), adherence to treatment (measured at each patient visit via the number of vials used for patients in the oral arm, and the number of injections given in the intramuscular arm), quality of life (measured using the EuroQoL-5D questionnaire), and patient satisfaction and preferences