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Safety profile Among the 165 subjects in the safety analysis population, 14 (21.54%), 19 (28.79%), and 11 (32.35%) patients reported one or more AEs in the Met+Sita, Met+Sita+Acarb, and Sita+Acarb group, respectively

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Rationale for choosing 50 g dose of vitamin B 12 Based on results from previous studies in this area, we expect the intake of vitamin B 12 among women in our study to be low, both due to a predominant plant-based diet and poor gut function that again may disturb vitamin B 12 absorption and increase dose requirements

The main risk is dehydration from gastrointestinal side effects

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