Woman and Man
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Extract
− To evaluate safety, tolerability, and efficacy of TMC207 as part of a multi-drug regimen in the treatment of subjects with MDR-TB; − To evaluate the pharmacokinetics of TMC207 and its primary metabolite M2, and pharmacokinetic/pharmacodynamic relationships for safety and efficacy. − To explore the effect of TMC207 on the experience of TB symptoms as measured by the Tuberculosis Symptoms Profile (TSP), and to explore the measurement properties of the TSP.
Inclusion criteria
- Sputum smear-positive pulmonary multi-drug resistant tuberculosis