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Flow chart of trial subjects. The main reasons for pre-screening failure included: Not interested (n = 85), missing signs of functional constipation (n = 220), insufficient blood glucose control (n = 24), not allowed concomitant medication, e.g., insulin (n = 58), body mass index ≥ 35 kg/m2 (n = 31) gastrointestinal or other relevant comorbidity (cancer, lactose intolerance etc.) (n = 39), smoking habit (n = 7). HbA1c: Glycosylated hemoglobin.
