Confidentiality {27}
All patients will have a random subject identification code that does not include any patient identifying data. The encrypted codebook will be digitally kept and will be safeguarded by the study physician. Other involved parties (data monitoring committee, Health and Youth Care Inspectorate) may be permitted access to patient data (including patient identifiers). This may be necessary to determine patient safety or whether the study is conducted in a safe manner. These involved stakeholders will maintain the confidentiality of identifying patient data.