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Glossary

Serious side effect

A side effect is considered “serious” when it results in the following: - death - puts the participant’s life at risk - causes the participant to have a stay in the hospital or stay there longer - causes disability - causes a baby being born with medical problems - the doctor thinks it may have turned into one of these problems if not treated

Side effect

A medical problem of the participant that happened during the study and that the doctor thought was due to the study drug