Flow Chart of Study Assessments. All study assessments will be conducted as indicated in Table 1, which displays the frequency and timing of all measurements.
Flow Chart of Study Assessments. Note: Any additional medical procedures not included into this study protocol can be performed within routine clinical practice in each medical institution Day 1 62 11-13 Informed consent X Randomization X Demographic data X Medical history X Pregnancy Test4 X Physical examination3 X X In- or outpatient X Stool frequency within the last 24 hours X Inclusion/exclusion criteria X Vitals signs X X Dispense study drug X Concomitant medication X X X Compliance check X Adverse events X X X Collect study drug X Dispense diary X1 Collect diary X 1 Subjects’ parent/caregivers have to fill in their daily diaries continuously.
Flow Chart of Study Assessments. All study assessments will be conducted as indicated in Table 2, which displays the frequency and timing of all measurements. Day 1 62 11-13 Informed consent X Inclusion/exclusion criteria X Demographic data X Medical history including vaccination history X Physical examination X X Vitals signs X X Dispense study drug X Concomitant medication X X X Compliance check X Global physician assessment X Adverse events X X X Collect study drug X Dispense diary X1 Collect diary X 1 Subjects’ parent(s)/caregiver(s)/legal representative(s) have to fill in their daily diaries continuously. 2 or within 24 hours (in exceptional justified cases within 48 hours) after recovery if this occurs before day 6
