Patient rights and obligations

1. Voluntariness of participation in the trial:

Participation in a clinical trial is entirely voluntary. The patient consents to participate by signing and

dating the Informed Consent Form.

2. Pre-decision:

• • The patient is given detailed information about the study, including:

  • Purpose and nature of the study.

  • The treatment to be used.

  • The planned procedures.

  • Possible adverse effects.

  • Other treatments available.

  • Obligations resulting from participation in the study.

3. right to withdraw from the study:

The patient has the right to withdraw from the study at any time, without having to give a reason. The

resignation does not affect access to standard treatment.

4. Right to compensation:

In the event of any harm resulting from participation in the study, the Patient is entitled to compensation

in accordance with the applicable legislation.

5. Costs related to participation in the study:

The patient shall not be paid for participation in the study, but shall not incur any costs related to

participation in the study. The patient shall be reimbursed for documented travel costs to appointments

related to the clinical trial.