Table 1 Assessment schedule for patients recruited{13}

Enrolment:

 Screening

 Informed consent

X

 Inclusion/exclusion criteria

X

 Chest CT

X

X

X

X

 Medical history and demographics

X

 Pregnancy test

X

X

X

X

 HIV test

X

 Symptoms/weight

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Physical examination

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Randomization

X

Interventions:

 Dispense/administer allocated TB treatment

X

X

X

X

X

X

X

X

X

X

X

X

Assessments:

 Study treatment adherence assessment

X

X

X

X

X

X

X

X

X

X

X

X

 Efficacy and safety evaluations

 Sputum smear

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Sputum culture

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Molecular DST

X

 Collect strains for phenotypic DST (only in case of positive sputum culture)

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Visual acuity testing

X

X

X

X

X

X

X

X

X

X

X

X

X

 Urinalysis

X

X

X

X

X

X

X

X

X

X

X

X

X

 Hematology

X

X

X

X

X

X

X

X

X

X

X

X

X

 Clinical chemistry^a

X

X

X

X

X

X

X

X

X

X

X

X

X

 Hepatitis B and C testing

X

 TSH^b

X

X

X

X

 ECG^c

X

X

X

X

X

X

X

X

X

X

X

X

X

 Ongoing participant review

 Concomitant therapy

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 AEs

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X