[51] Diagnosis [edit] According to one review: "At present, no 'gold standard' test exists for the diagnosis of vitamin B 12 deficiency and as a consequence the diagnosis requires consideration of both the clinical state of the patient and the results of investigations." [52] The vitamin deficiency is typically suspected when a routine complete blood count shows anemia with an elevated mean corpuscular volume (MCV)
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Its pivotal trial enrolled 816 participants and met its primary efficacy endpoint, supporting FDA approval in 2010 with documented visceral fat reductions of roughly 15-18% over 26 weeks