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All the evaluations for assessment were administered in the form of scales or questionnaires completed by the patients without any interference by the clinicians, at baseline and during the subsequent visits, as routine evaluations

The relative abundances of Clostridium subcluster 4 of bacteria in the fecal samples were evaluated using quantitative PCR, which was performed using SYBR Green (Takara Bio, Kusatsu, Shiga, Japan) and an Mx3000P real-time PCR system (Agilent Technologies Japan Ltd., Tokyo, Japan), as reported previously [9]