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Protocol 2 In a non-comparative clinical and microbiologic trial performed in the United States, where significant rates of beta-lactamase producing organisms (35%) were found, 131 patients were evaluable for clinical efficacy

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Some patients want to discontinue the treatment because of side effects like nausea, diarrhea or constipation

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A commenter recommended that CMS monitor ASC feedback during the voluntary reporting period to ensure ASCs do not face widespread technical or operational challenges which would require postponing mandatory implementation