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Article History

Received: 31 May 2022

Accepted: 19 December 2022

First Online: 9 January 2023

Declarations

:

: Relevant regulatory and ethical approvals were obtained from the Investigational Review Board (IRB) South Korea before initiating the study. Each patient provided their written consent according to local requirements after the nature of this observational research was fully explained and before any study-related data were collected. The registry Informed Consent Form used was approved by the reviewing ethics committee in accordance with applicable regulatory requirements. Methods of collection were carried out in accordance with relevant guidelines and regulations. A database and electronic clinical report form (eCRF) were created for the purposes of the registry. Data were collected at each site as per routine clinical practice and collated in the Oracle Remote Data Capture (OC-RDC) onsite system (v4.6.6) developed for the registry and maintained by a contract research organisation (Syneos Health).

: Not applicable.

: TSS, JHM, SHL, Y-SK, JCC and, JSP have no conflicts of interest. HP, EB, GM, LA, KD, FT-B, JHK, HK, and NB are employees of Janssen Pharmaceuticals, participating in the development of bedaquiline, and all are potential stockholders of Johnson & Johnson.