Women who are pregnant or breast-feeding cannot participate in this study. Women must not become pregnant during the study. Men should keep in mind that their partner must not become pregnant during the study. Inform your partner about this. It is because this study may have consequences for an unborn child. [if known, state which consequences] OR The consequences are not known. It is important for you to tell your partner about it. The investigator will talk to you about the most suitable contraceptives. If you or your partner still become(s) pregnant during the study, you should immediately tell the investigator. The pregnancy will then be monitored more closely [and reported to the sponsor of this study]. Separate consent will be asked for monitoring of the pregnancy. END OF EXAMPLE PASSAGE Possible [side effects/complications (and other)/undesirable effects/discomforts] [the medicine/the procedure under investigation/therapy] may cause [side effects/undesirable effects]. EXAMPLE PASSAGE <if there are any hazardous/urgent side effects> You should immediately contact the investigator if you develop: - - - END OF EXAMPLE PASSAGE These [adverse effects/discomforts/side effects] are common (occur in 1 in 10 people or more): … … <if there is any particular advice for any of the side effects, state this immediately under the side effect, e.g.: it may help to…> [adverse effects/discomforts/side effects] occur, but not as often: … … <if there is any particular advice for any of the side effects, state this immediately under the side effect, e.g.: it may help to…> [the medicine/the procedure under investigation/therapy] may also have [adverse effects/side effects] that are still unknown.
Women who are pregnant or breast-feeding cannot participate in this study. Women must not become pregnant during the study. Men should keep in mind that their partner must not become pregnant during the study. Inform your partner about this. It is because this study may have consequences for an unborn child. [if known, state which consequences] OR The consequences are not known. It is important for you to tell your partner about it. The investigator will talk to you about the most suitable contraceptives. If you or your partner still become(s) pregnant during the study, you should immediately tell the investigator. The pregnancy will then be monitored more closely [and reported to the sponsor of this study]. Separate consent will be asked for monitoring of the pregnancy. END OF EXAMPLE PASSAGE Possible [side effects/complications (and other)/undesirable effects/discomforts] [the medicine/the procedure under investigation/therapy] may cause [side effects/undesirable effects]. EXAMPLE PASSAGE <if there are any hazardous/urgent side effects> You should immediately contact the investigator if you develop: - - - END OF EXAMPLE PASSAGE These [adverse effects/discomforts/side effects] are common (occur in 1 in 10 people or more): … … <if there is any particular advice for any of the side effects, state this immediately under the side effect, e.g.: it may help to…> [adverse effects/discomforts/side effects] occur, but not as often: … … <if there is any particular advice for any of the side effects, state this immediately under the side effect, e.g.: it may help to…> [the medicine/the procedure under investigation/therapy] may also have [adverse effects/side effects] that are still unknown.