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Table 2 Discontinuation criteria

From: Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial

Severe hypoglycemia
Seriously poor glycemic control (HbA1c ≥10.0%)
Development of diabetic ketoacidosis
Serious dehydration requiring rehydration therapy
Considered inappropriate to continue the trial by investigators due to aggravation of primary disease or complications
Considered inappropriate to continue the trial by investigators due to adverse side effects of the trial drug
Considered inappropriate to continue the trial by investigators due to some other reasons
Participant withdrawal of consent