|
Visit
|
Basal and randomization, day 0
|
Day 3 ± 1
|
Day 12 ± 2
| |
|---|
|
V#1
|
V#2
|
V#3
|
EOS
|
EOF
|
|---|
|
Informed consent
|
X
|
–
|
–
|
–
|
–
|
|
Inclusion/exclusion criteria
|
X
|
–
|
–
|
–
|
–
|
|
Demographic data and medical history
|
X
|
–
|
–
|
–
|
–
|
|
Concomitant medication
|
X
|
–
|
–
|
–
|
–
|
|
Vital signs*
|
X
|
X
|
–
|
–
|
–
|
|
Anthropometric data^
|
X
|
–
|
–
|
–
|
–
|
|
Basal laboratory
|
X
|
–
|
–
|
–
|
–
|
|
PCR swab
|
–
|
X
|
X
|
–
|
–
|
|
Assessment of adverse events
|
–
|
X
|
X
|
X
|
–
|
|
Final objective evaluation
|
–
|
X
|
X
|
X
|
X
|
|
Randomization
|
X
|
–
|
–
|
–
|
–
|
|
Adherence to treatment
|
X
|
X
|
–
|
–
|
–
|
- *Includes heart rate, temperature, and oxygen saturation by a digital saturometer
- ^Includes weight and height
