Your rights as a participant

Your participation in this trial is voluntary. It will not reduce the possibilities or advantages you would otherwise have had and it will not obstruct your continued medical treatment if you do not wish to participate in the trial.

• You have the right to ask for time for reflection after the oral and written information, before you give your final written consent with your signature below. You have the right to bring a family member or an independent advisor to the information meeting
• Depending on the level of funding obtained compensation to subjects for transportation and lost income will be offered to participating subjects. In Denmark all research subjects are covered by the Health Insurance Act, and potential injury will be covered by the State of Denmark. Private patient insurance will be secured in recruiting centers not covered by national insurances.
• You have the right to see all the documents, if these documents contain no information about other participants or business secrets.
• Furthermore, you have the right to be informed of the results of the trial.
• You have the right to ask questions concerning possible and/or known risks of the trial at any time. You will be kept informed about all important new approaches in regard to changes of the trial, new effects of the drug, new side effects of the trial drug, or new risks regarding participation.
• You can withdraw from the trial at any time and you do not have to give a reason why.
• If you at any time should decide to withdraw from the trial, it will not have any effect on your normal laboratory and outpatient clinic visits.
• The trial doctor can exclude you from the trial at any time if we consider this best for you.