5. Please specify exact number of volunteers instead of “up to 12 male-born participants”.
6. Please mentionyour protocol foradministering the study drug and the collection of rectal tissue in your project summary.
7. Please providethe objective of the study as well as the methodology of the study within the questionnaire and interviews,as well as in the participant information sheet to provide information to volunteer participants.
8. Questionnaires and interviews are very sensitive. You should add the option of
“I don’t want to answer” for all questions for those volunteers who prefer not to answer. The committee will send your questionnaire to an expert for review, after which we will send the result to you.