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Second, many available studies are characterized by small sample sizes or lack appropriate control groups, making it difficult to draw definitive conclusions about therapeutic efficacy and optimal treatment protocols

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Prescription Requirements and Medical Oversight To ensure safe and effective treatment, Vitamin B12 injections must be prescribed and administered under medical guidance

Finally, given the pragmatic nature of the proposed trial, the decision was taken to include consecutive patients seeking medical help at the participating centres, thus ensuring the enrolment of subjects similar to those that would be seen in normal clinical practice