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Suggested Consent Language: Pregnancy

ORI

Procedure Language

Copy/Paste the following to the section labeled B. Procedures:

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Risk Language

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We do not know if the study drug will affect mother’s milk or an unborn fetus. Therefore, breast-feeding and pregnant women are not allowed to take part in the study. If you are pregnant or become pregnant, there may be risks to the embryo or fetus that are unknown at this time. [Note to PI] If there are specific known risks for your treatment, please include. Women who can become pregnant must take a pregnancy test before the start of the study.

You should not father a child while on this study as the treatment may indirectly affect an unborn child. If you are sexually active and are at risk of causing a pregnancy, you and your female partner(s) must use a method to avoid pregnancy that works well or you must not have sex.

Unless you cannot have children because of surgery or other medical reasons, you must be using an effective form of birth control before you start the study. You must also agree to continue to use an effective form of birth control for [Insert number] month/s after taking the study drug.