Chaulet 1995.

Methods	Design: RCT Generation of allocation: not stated Allocation concealment: not stated Blinding: not stated Duration: not mentioned
Participants	Number of participants: 250 randomized Males: 74% (of 196 participants initially sensitive to isoniazid) Inclusion criteria: new pulmonary TB participants (aged 15 or more) confirmed by chest x‐ray and sputum smear. They should lived in Algiers and accepted medical monitoring for 2 years Exclusion criteria: not reported Completeness of follow‐up: 86% (ITT population) Baseline drug susceptibility test: initially drug resistant participants 8.4% (16/190 tested); (FDCs H:2, S:4, H&S:4 and single‐drug formulations H:2, S:2, H&S:4) HIV status of participants: not reported
Interventions	Six months treatment regimen (2HRZ/4HR) Intensive phase (8 weeks) Intervention 3FDCs (isoniazid 50 mg, rifampicin 120 mg and pyrazinamide 300 mg per tablet) (N = 124). Doses used: 4 tablets for participants weighing less than 44 kg, 5 tablets for participants weighing 44 to 50 kg and 6 tablets for participants weighing ≥ 50 kg Control The same drugs as single formulations (N = 126). Doses used: isoniazid 300 mg; rifampicin 450 mg for participants weighing < 50 kg and 600 mg for ≥ 50 kg; and pyrazinamide 1500 mg for participants weighing < 50 kg and 2000 mg for ≥ 50 kg Continuation phase (20 weeks) 2FDCs (isoniazid and rifampicin) for all participants: 3 tablets (isoniazid 100 mg and rifampicin 150 mg per tablet) for participants weighing < 50 kg and 2 tablets (isoniazid 150 mg and rifampicin 300 mg per tablet) for participants weighing > 50 kg. Treatment was administered daily for the whole course, as directly observed treatment (DOT) with participants kept at hospital under supervision of health personnel at the beginning of intensive phase and as outpatients and self‐administered the rest of the time
Outcomes	Outcomes used in this review Culture conversion at 2 months after initiation of treatment. Treatment failure. Relapse. Adverse events: those leading to discontinuation of therapy and other adverse events. Acquisition of drug resistance. Treatment adherence. General satisfaction with formulations.
Notes	Three publications for the same clinical trial (Agounitestane 1990; Bellabas 1989; Chaulet 1995). Most outcomes were assessed according to the data provided in Chaulet 1995, the most recent publication. Preliminary results had been previously published (Agounitestane 1990; Bellabas 1989) Location: Algeria Setting: The Matiben Chest Clinic at the West Algiers University Teaching Hospital and 3 other outpatient clinics in Algiers Source of funding: National Institute of Higher Medical Sciences in Algiers and the Ministry of Health Comments follow‐up duration was 2 years after initiation of treatment. Sputum smears and culture were examined at 8, 24, and 28 weeks, and every 6 months (follow‐up) after initiation of treatment. Adverse events were assessed at each visit and at 2 months. For the treatment adherence time to follow‐up was not reported. Patient satisfaction with formulations was noted at 2 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information about random sequence generation process to permit judgement of ‘low risk’ or ‘high risk’.
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment of ‘low risk’ or ‘high risk’.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Due to difficulties in blinding participants and personnel to the intervention, when the study did not specify blinding methods we considered it as an open design. In addition, outcomes were unlikely to be influenced by lack of blinding (objective and measurable outcomes).
Blinding of outcome assessment (detection bias) All outcomes	Low risk	No blinding of outcome assessment, but outcome measurement is unlikely to be influenced by lack of blinding (objective and measurable outcomes).
Incomplete outcome data (attrition bias) All outcomes	High risk	Reasons for missing outcome data were not reported.
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement of ‘low risk’ or ‘high risk’.
Other bias	Low risk	The trial appears to be free of other sources of bias.