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. Author manuscript; available in PMC: 2022 Mar 14.
Published in final edited form as: N Engl J Med. 2022 Mar 10;386(10):911–922. doi: 10.1056/NEJMoa2104535

Table 2a. Components of the primary mITT analysis.

16 weeks 24 weeks Total
Randomised 602 602 1204
Included in analysis (assessable) 572 573 1145
Favourable Completed treatment and clinically well (without retreatment or otherwise unfavourable) at 72 weeks 556 555 1111
Total favourable (% of assessable) 556 (97) 555 (97) 1111 (97)
Unfavourable Death from any cause after week 16 7 12 19
LTFU after week 16 but during treatment period 0 1 1
TB events TB recurrence 6 4 10
Treatment extension (treatment failure) 2 0 2
Restart* (treatment failure) 1 1 2
Total unfavourable (% of assessable) 16 (3) 18 (3) 34 (3)

Data presented as number of participants (%). mITT = modified intention to treat.

*

Both participants had treatment restarted after defaulting on treatment.