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An evaluation of designs for Phase I/IIa dose-finding studies in Tuberculosis

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Statistical Methods in Medical Research: An International Review Journal

Published online on

Abstract

Statistical Methods in Medical Research, Volume 35, Issue 7, Page 1349-1365, July 2026.
Early development of tuberculosis (TB) treatments often separates dose-finding in healthy volunteers (Phase I) and safety and early activity in patients (Phase IIa). The BTZ-043 study (NCT04044001) is a recent study that combined these two objectives in ...