All (potential) medicines can cause side effects. Because the compound has not yet been administered to humans, there are currently no known side effects in humans. The new compound has been studied extensively in the laboratory and in animals. Some side effects have been found in animal studies; these effects are dose dependent and specific criteria have been applied to minimize the likelihood of them occurring at the doses to be administered in this study. Effects observed include effects on the gastrointestinal tract (weight loss, vomiting, and at high doses blood in the stool and/or damage to tissue in the intestines) and effects on the eyes (watery or mucus-like eye discharge, and at high doses changes to the surface of the eye (cornea)or changes to the lens of the eye). Skin rash and hair loss were observed but it is not known if they were caused by the study compound. Tremors (trembling), and at very high drug concentrations, substantially higher than will be experienced in this trial, convulsions (sudden, uncontrolled muscle movements) were seen. In rare cases (<0.1%), serious side effects can occur during the first administration to humans. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects based on these animal tests. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.
