| Characteristics | Randomised in Trial 204 | Analysis population# |
| Subjects n | 481 | 421 |
| Age years | 35 (18–63) | 34 (18–63) |
| Males | 324 (67.4) | 278 (66.0) |
| Region | ||
| Americas | 133 (27.7) | 125 (29.7) |
| Southeast Asia | 150 (31.2) | 144 (34.2) |
| Northeast Asia | 106 (22.0) | 81 (19.2) |
| Eastern Europe or Mediterranean | 92 (19.1) | 71 (16.9) |
| XDR-TB | 72 (15.0) | 56 (13.3) |
| Lung cavities | ||
| Absent | 153 (31.8) | 137 (32.5) |
| Unilateral | 213 (44.3) | 188 (44.7) |
| Bilateral | 115 (23.9) | 96 (22.8) |
| Previous treatment | ||
| First-line only | 295 (61.3) | 272 (64.6) |
| Second-line with or without first-line | 138 (28.7) | 110 (26.1) |
| Third-line with or without first-line or second-line | 48 (10) | 39 (9.3) |
Data are presented as median (range) or n (%), unless otherwise stated. XDR-TB: extensively drug-resistant tuberculosis. #: included all patients randomised in Trial 204 who also consented to participate in Study 116, and who had microbiological data to support assessment of treatment outcomes using solid culture media.