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No severe or confirmed hypoglycaemic episodes were reported in the two trials and there were no clinically relevant observations related to vital signs, physical examination, electrocardiogram or laboratory safety parameters, except temporary asymptomatic increases in lipase levels in two subjects at follow-up in the dosing conditions trial (from 46 U/L at screening to 231 U/L at follow-up and from 59 U/L at screening to 378 U/L at follow-up [normal range 1360 U/L])

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Continuous variables were categorized into intervals as relevant

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