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 | – | – | – |