4.3.5 Pregnant and breastfeeding women

Pregnant and breastfeeding women were excluded from both the ZeNix and TB-PRACTECAL trials; therefore, no analysis specific to this subgroup of patients could be performed, and safety of the BPaLM/ BPaL regimen, especially of pretomanid, in pregnant and breastfeeding women has not been established. For pregnant and breastfeeding women, the longer 9-month oral regimen can be used (Chapter 5).

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