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http://82.221.129.208/.uo4.html

8.3.5.1. Exposure During Pregnancy

An EDP occurs if:

• A female participant is found to be pregnant while receiving or after discontinuing study intervention.

• A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception.

• A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure.

Below are examples of environmental exposure during pregnancy:

• A female family member or healthcare provider reports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact.

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• A male family member 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.

The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred. The initial information submitted should include the anticipated date of delivery (see below for information related to termination of pregnancy).