84 Chapter 4 in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Availability of data and materials Not applicable as this is a protocol for a study. Ethics approval and consent to participate This study has been reviewed and approved by the Medical Research Ethics Committee of the University Medical Center Utrecht, the Netherlands (ISRCTN 94074203) for all centre sites and will be conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants. Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests.
RkJQdWJsaXNoZXIy MTk4NDMw