Reporting Each serious adverse event (SAE) will be investigated thoroughly and an assessment will be made whether the SAE is a suspected unexpected serious adverse reaction (SUSAR, i.e. unexpected and drug-related, as indicated in the most recent Summary of product characteristics (SPC) provided by the drug supplier). Because this study is an investigator sponsored trial (IST), the investigator also acts as sponsor. Therefore, the investigator will be responsible for reporting the SAEs and SUSARs to the accredited ERB. This will be done within 15 days after first knowledge, using the specified web portal ('ToetsingOnline'), which automatically leads to informing the respective national health authorities. For fatal or life threatening SAEs and SUSARs this term will be 7 days for a preliminary report ('expedited') with another 8 days for completion of the report. The expedited reporting through the web portal 'ToetsingOnline' is sufficient as notification to the competent authority. Since this study is a monocenter study, no other sites have to be informed.