Title	A phase IIb, open-label, randomized controlled dose ranging multi-center trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-positive, drug-sensitive pulmonary tuberculosis Trial acronym: DECODE (PanACEA DElpazolid dose-finding and COmbination DEvelopment)
Trial registration {2a and 2b}.	NCT04550832 16/09/2020 Clinicaltrials.gov
Protocol version {3}	Version 2.1 – 08.09.2021
Funding {4}	This trial is funded by LegoChem Biosciences. LegoChem Biosciences will also supply the treatment with delpazolid.
Author details {5a}	1LMU University Hospital Munich, Division of Infectious Diseases and Tropical Medicine, Munich, Germany 2German Center for Infection Research (DZIF), Munich partner site, Munich, Germany 3Ninewells Hospital and Medical School, NHS Tayside, Dundee, UK 4Department of Pharmacy, Radboud University Medical Centre, Nijmegen, The Netherlands 5Department of Pharmacy, Uppsala University, Uppsala, Sweden 6UCL Centre for Clinical Microbiology, Division of Infection & Immunity, University College of London. UK. 7University of California San Francisco, Department of Medicine, Division of Pulmonary & Critical Care Medicine, San Francisco, United States 8National Institute for Medical Research – Mbeya Medical Research Centre (NIMR-MMRC), Mbeya, Tanzania 9Kilimanjaro Clinical Research Institute, Kilimanjaro, Tanzania 10The Aurum Institute, Tembisa, South Africa 11Ifakara Health Institute, Dar es Salaam, Tanzania 12Clinical HIV Research Unit, Helen Joseph Hospital, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa 13Consultant, LegoChem Biosciences, South Korea 14LegoChem Biosciences, South Korea
Name and contact information for the trial sponsor {5b}	LegoChem Biosciences, Inc. 10, Gukjrgwahak 10-ro, Yuseong-gu Daejeon Republic of Korea
Role of sponsor {5c}	The trial sponsor will have the ultimate decision on trial design, data collection, data management, analysis, and interpretation of data, writing of the clinical study report, and the decision to publish the clinical study report. The PanACEA Consortium authors were contracted by the sponsor to advise on the activities above. PanACEA authors have a contractually agreed freedom to publish study results; the sponsor has the right to comment on manuscripts prior to publication.