Protocol modifications
If any modifications to the protocol are made, these are submitted to the medical ethical committee for approval. This will be done by a protocol amendment. Once the amendment is approved, it will be communicated to the team involved in the study verbally, by e-mail, and by modification of the study protocol which is available at the outpatient clinic. Other relevant parties such as trial registries and journals will be informed by e-mail. If the modification is relevant for previously included participants, they will be informed verbally by phone or during their visit to the outpatient clinic.