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Individuals currently or previously treated with insulin on a regular basis, with recurrent severe hypoglycaemia or hypoglycaemia unawareness, blood pressure outside 90159 mmHg (systolic) or 5099 mmHg (diastolic), or history of or presence of clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions (except mild complications associated with diabetes), as well as pregnant women, were excluded from participation

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