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In its Complete Response Letter, FDA said results from the Phase III ROMAN trial, in combination with the GT-201 trial, were not sufficiently persuasive to establish substantial evidence of avasopasems effectiveness and safety in reducing these mouth sores

This is particularly important if you are part of any of the groups considered to be at high risk of B12 deficiency, including alcoholics, smokers, those on diabetes drugs, adults over 65, those with gastrointestinal disorders and those who have had surgery relating to the digestive tract

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