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Patients were allowed to use a stable dose of medication for UC, except for biologicals or corticosteroids >10 mg per day, and had not used antibiotics in the 6 weeks before inclusion.
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Patients were required to be using a stable dose of metformin (≥1,000 mg/day) alone or in combination with a stable dose of SU (as a separate formulation) for at least 3 months before randomization.
Alternatively, opioids such as methadone can often be used as a stable dose in severe patients without any problems.
Participants who used drugs with anticholinergic or narcotic properties were excluded, but the use of a stable dose of cholinesterase inhibitors was allowed.
Treatment, if needed, was at their psychiatrists' discretion, but it was recommended the use of a stable dose during the study's period.
Use a stable 9 volt power supply.
Entry criteria included the following: use of metformin at a stable dose of at least 1.5 g/day for at least 3 months alone or in combination with a sulfonylurea or glinide or a thiazolidinedione (TZD), or a combination of these; HbA1c ≥7.0 and ≤10% (≥53 to ≤86 mmol/mol); and BMI >20 kg/m.
Candidates using metformin must have taken a stable dose of at least 1.5 g/day (South Korea, at least 1.0 g/day) for at least 3 months before screening.
A summary of permitted and prohibited medications, from 12 weeks prior to screening and throughout the study, and study withdrawal criteria, are provided in Additional file 1. Patients entered a 4-week run-in period, during which they used their baseline ICS at a stable dose, but stopped any non-corticosteroid controller medication.
Use of short-acting β2-agonists and use of inhaled corticosteroids (ICS) at a stable dose by the COPD patients was permitted during the study period.
If used at enrollment, metformin was continued at a stable dose throughout the study.
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