Schedule items | Enrolment | Randomisation | Baseline | Testing: Dose 1 | Testing: Dose 2 |
---|---|---|---|---|---|
Time point | T0 | T45 min | |||
Enrolment | |||||
Eligibility screening | X | ||||
Informed consent/assent | X | ||||
Allocation | X | ||||
Interventions | |||||
Dose 1 | X | ||||
Dose 2 | X | ||||
Assessments | |||||
Clinical history | X | ||||
Recent relevant medications | X | ||||
Adverse events | X | X | |||
Saliva sample (for DNA work) | X | ||||
Rint assessment | X | X | X | ||
Urine sampling | X | X |