Table 3

Study schedule of enrolment, interventions and assessments.

		Study period
		Enrolment	Allocation	Intensive phase of ATT (Trial period)								Continuation phase of ATT (Post-trial period)				Closeout
I	Enrolment	Baseline (-D7)	W 0	W 1	W 2	W 3	W 4	W 5	W 6	W 7	W 8	M 3	M 4	M 5	M 6	M 7
1	Informed consent	x
2	Eligibility screen (including laboratory tests)	x
3	Sputum Gene Xpert	x
4	HIV, hepatitis B and C	x
II.	Allocation		x
III	Trial regimens
	Test regimen (metformin containing ATT)		x	x	x	x	x	x	x	x	x
	Control regimen (only ATT)			x	x	x	x	x	x	x	x
	Continuation phase of ATT (for both groups)											x	x	x	x
IV	Assessments
1	Clinical evaluation	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
2	Sociological assessment	x	x				x				x	x	x	x	x	x
3	Sputum smear and culture (MGIT, LJ)	x		x	x	x	x	x	x	x	x	x	x	x	x
4	Urine pregnancy tests/sugar/Alb	x					x				x	x	x	x	x
5	HbA1c	x									x				x
6	CBC, LFT, RFT, lactic acid, peripheral smear and chest X-ray	x					x				x				x
7	Random blood sugar	x			x		x		x		x				x
8	Pharmacokinetics and genomics						x				x
9	Immunological studies		x								x				x
10	Storage plasma/cell sample		x				x				x				x
V	Outcomes															x