Consent for publication {32}
A consent form which is revised and adapted by the Ethics Committees of participating centres is part of the informed consent process. This consent form includes information about the purpose of the trial, the potential benefits and risks, the right to refuse participation or to withdraw consent at any time, the institutional affiliation and potential competing interests of the researcher, and the sources of trial funding. Model consent forms (in German language) are available on reasonable request from the principal investigator.