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Data-sharing requests relating to data in this manuscript will be considered after the publication date and either (1) when this product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or (2) when clinical development discontinues and the data will not be submitted to regulatory authorities

Confirm FDA, CE, or other relevant market registrations

Efficiency of the sublingual route in treating B12 deficiency in infants

CDER is recommending that manufacturers conduct risk assessments on drug product packaged in infusion bags

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