Fig 1.
Schedule of enrollment intervention and assessments.
CI or SIs must obtain written consent by the screening test. The maximum screening period (from consent acquisition to registration / randomization) is 3 days. CI or SIs must start protocol treatment within 4 days of obtaining consent. Predetermined observations, investigations, and tests must be performed prior to administration of the study drug. If the decision to terminate the pregnancy is made before the protocol treatment is completed, the protocol treatment must be terminated at that point, and the patient shifts to the post-pregnancy observation period after delivery.
Table 1.
Schedule of data collection and monitoring for participant (mother and fetus).
Table 2.
Schedule of data collection and monitoring for participant (infant).
Table 3.
Planned statistical analysis.