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SAEs relatedness to the administration of vitamin B 12 or placebo will be judged by the investigator/designee, the Ethics Committee and the DSMB who will have access to all relevant investigations, clinical assessments and if require unblinding allocated interventions

The team takes time to understand each individuals symptoms, lifestyle, and concerns before developing a customized treatment strategy

It is a research compound that has not been approved for human use by the TGA

If the distribution of confounding factors differs in the two arms, explicative regression analysis will be performed in which the dependent variable will be the normalisation of the serum vitamin B12 concentration, and the independent variable will be the treatment group

[DOI: 10.1002/14651858.CD004655.pub2] [DOI] [PMC free article] [PubMed] [Google Scholar]