A phase 1/2/3, placebo-controlled, randomized, observer-blind

… Participants are excluded from the study if any of the following criteria apply [ 5.2 ]

… Women who are pregnant or breastfeeding [ 5.2.11 ]

… Study intervention is defined as any … intended to be administered to a study participant [ 6 ]

… A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception [ 8.3.5.1 ]

… A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure [ 8.3.5.1 ]

… or healthcare provider reports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact [ 8.3.5.1 ]

… or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception [ 8.3.5.1 ]

… a female family member or healthcare provider who reports that she is breastfeeding after having been exposed to the study intervention by inhalation or skin contact [ 8.3.5.2 ]

… A female participant is eligible to participate if she is not pregnant or breastfeeding [ 10.4.2 ]

 

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