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FDA's evaluation concluded that the criteria weighed against placement on the list, citing inadequate physicochemical characterization, immunogenicity concerns from impurities and aggregates, lack of clinical effectiveness data for any approved use, and absence of published human exposure data for the proposed subcutaneous and topical routes
Vitamin B12 is generally very safe, and side effects are rare
Failing any one means discard it
this effect may be due to interference with erythrocyte maturation
Some studies employ a loading regimen of higher initial doses followed by lower maintenance doses
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