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SAE’s 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

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Athletes and those subject to anti-doping rules should be aware that many peptide compounds are prohibited by the World Anti-Doping Agency (WADA) and UK Anti-Doping (UKAD)