Accrual and analysis exclusions
neurocognitive toxicity
A total of 956 women were enrolled in P1078 between August 2014 and April 2016 at 13 sites in eight countries. Of the women enrolled in P1078, 749 women, 370 in the Immediate INH arm and 379 in the Deferred INH arm, had at least one neurocognitive toxicity evaluation. These women were included in the neurocognitive analysis set (Fig. Randomization and analysis sets