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During these home observations, intake of study food is recorded.
All hypoglycemic events occurred >28 days after intake of study medication, and none required assistance.
Intake of study medication and adverse events were interviewed after the end of treatment.
Hemodynamic and echocardiographic parameters were recorded at regular intervals up to 6 h after intake of study drug.
Weeks were calculated as 168-h intervals starting with the exact time of the first intake of study medication.
There were 3 patients with no evidence of intake of study drug, and these were excluded from the safety population.
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Part 5 of the web appendix shows intakes of target nutrients at each study time point.
Dose intakes of study medication were noted in the patient diaries.
Other assessments included formula intake, tolerance of study feeding, stooling patterns and consistency, physician evaluation of clinical symptoms, and blood biochemistry levels.
Total study formula intake: volume of study formula taken from admission until cessation of diarrhea or for a maximum of 120 hours if diarrhea continues, expressed in milliliters per kilogram of body weight.
Study start is the first day of intake of the study substance.
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