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The trial protocol was approved by the Madrid Region Clinical Research Ethics Committee ( Comit tico de Investigacin Clnica Regional de la Comunidad de Madrid ) on February 8 th 2011, and has been registered with ClinicalTrials.gov number NCT 01476007, and under EUDRACT number 2010-024129-20 [Oral Versus Intramuscular Cobalamin to treat Cobalamin Deficiency: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary healthcare setting (OB12 project)]

The mixture is then filtered through sterilizing filters (0.22 m) and filled into sterile vials in an aseptic environment

Proper reconstitution requires injecting water slowly down the vial wall

it is essential for healing yet can result in prolonged tissue damage if it persists excessively