Efficacy Measurements. Primary Efficacy Variable: Duration of diarrhea (hours) between the start of treatment until the last watery/diarrheal stool before recovery or the end of study treatment (treatment duration maximal 5 days). Treatment will stop at recovery or after the morning dose of day 6, if not recovered. Duration of diarrhea is defined as date and time of the evacuation of the final watery/diarrheal stool before recovery derived from the daily diary. Secondary Efficacy Variables: • Time until recovery, defined as date and time of the evacuation of the first of two consecutive normal stools or no stool within 12 hours after the first normal stool. • Number of recovered subjects in total and until each individual treatment day. • Global Physician Assessment (GPA) at the end of treatment, at the discretion of the investigator:
o 1 = Complete relief of acute diarrhea, o 2 = marked improvement of acute diarrhea, o 3 = moderate improvement of acute diarrhea, o 4 = slight improvement of acute diarrhea, o 5 = no change in acute diarrhea, o 6 = worsening of acute diarrhea. (Treatment success = GPA score of 1 or 2). • For toilet trained children only: number of stools per day as well as number of watery stools per day from start of treatment and until end of study treatment.
Efficacy Measurements. Primary Efficacy Variable: Duration of diarrhea (hours) between the start of treatment until last diarrheal/watery stool before recovery or end of study treatment (treatment duration maximal 5 days). Treatment will stop at recovery or after the morning dose of day 6, if not recovered. Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary.
