. 2023 Jun 28;24:435. doi: 10.1186/s13063-023-07448-0

Table 2.

Schedule of events with planned visits

Time point (weeks)	Screening and BL	Intervention (SoC + placebo/ASA/Ibu)								DS and MDR follow-up ON Rx						MDR/Rx treatment extension	Final visit end of FU^c
Time point (weeks)	*− 7 to 0 days*	1	2	3	4	5	6	7	8	9	10	12	16	20	24^a	*Extra visit at the completion of TB treatment*^b	*6 months after the treatment completion date*
TB score	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Eligibility screen	X
Informed consent	X
Randomization	X
Clinical examination	X	X	X		X				X			X	X	X	X	X	X
HIV test if required	X
CD4 and HIV RNA	X
Pregnancy test if female	X				X				X
Sputum culture	X	X	X		X		X		X			X	X	X	X	X	X
12-lead ECG if MDR	X				X				X
Pulse oximetry, Hb, symptom check, weight, abdominal circumference, MUAC, and anonymized photo	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Chest X-ray	X								X						X
Spirometry	X								X						X
HQoL questionnaires	X				X				X						X		X
Sample collections for host and pathogen biomarkers	X	X	X		X				X						X	X	X
Safety evaluation	X	X	X		X		X		X			X	X	X	X	X	X
Safety lab test	X	X	X		X		X		X			X	X	X	X	X	X
PK studies^d			X									X
Adherence check		X	X	X	X	X	X	X	X			X	X	X	X	X	X

^aIn DS-TB patients, week 24 coincides with treatment completion

^bAn extra visit will be performed at the end of treatment for the MDR-TB group. If TB treatment is extended for more than 15 days in the DS-TB group, an additional treatment completion visit will be conducted

^cAll patients will be followed-up for 6 months (24 weeks) after treatment completion, to investigate relapse

^dPK studies will be performed on selected participants in South Africa only