Screening Treatment | Follow-up | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 (G) | 18 (T) |
Weeks (W) | W −1 | W 0 | W4 | W 8 | W 12 | W 16 | W 20 | W 24 | W 28 | W 36 | W 44 | W 52 | W 60 | W 72 | W 84 | W 96 | W 108 | W 112 | W120 |
Demographics | X | ||||||||||||||||||
Medical history | X | ||||||||||||||||||
Previous treatment | X | ||||||||||||||||||
Inclusion and exclusion criteria | X | X | |||||||||||||||||
Subject information Informed Consent | X | ||||||||||||||||||
Physical examination | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | Xa | Xb |
Pregnancy test | X | Xa | Xb | ||||||||||||||||
HIV test | X | ||||||||||||||||||
Laboratory tests and B/Sc | X | Xd | X | X | Xf | Xa | Xb | ||||||||||||
12-lead ECG | X | X | X | Xa | Xb | ||||||||||||||
MGIT test | X | ||||||||||||||||||
Sputum smear | X | X | X|e | X | X | X | X | X | X | X | X | X | X | X | X | X A | Xb | ||
Sputum culture | X | X | X|e | X | X | X | X | X | X | X | X | X | X | X | X | Xa | Xb | ||
Indirect drug susceptibility testing | X | X | X | X | X | X | X | X | X | X | X | X | X | X | Xa | Xb | |||
Chest X-ray | X | Xa | Xb | ||||||||||||||||
Randomization | X | ||||||||||||||||||
Adverse events/and events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | Xa | Xb | ||
Concomitant therapy check | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | Xa | Xb | |
Compliance check | X | X | X | X | Xb | Xb |