Clinical/laboratory event | Corresponding visit/time schedule | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | V10 | |
T-12 | T-8 | T-4 | T0 | T2 | T4 | T8 | T12 | 16 | T20 | |
Screening | √ | |||||||||
Visit | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Vitals | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Clinical | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Previous current medication | √ | |||||||||
Past history | √ | |||||||||
Physical Examination | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Laboratory Sample Collection | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Inclusion criteria | √ | √ |