Funding for this research was provided by:
KWF Kankerbestrijding (10327/2016-1)
Received: 4 July 2018
Accepted: 22 August 2018
First Online: 10 September 2018
Ethics approval and consent to participate
: This study is conducted in agreement with either the Declaration of Helsinki or the laws and regulations of the country, whichever provides the greatest protection of the patient. The protocol has been written, and the study is conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice. The CRITICS-II trial has been approved by the medical ethics committee of the Antoni van Leeuwenhoek, Amsterdam. Patients receive both oral and written information about the study. Written informed consent will be obtained before any study procedures. Most recent protocol version is version 3.1 and was approved by the medical ethics committee at 18 April 2018. The sponsor/investigator has a liability insurance that provides cover for manage to research subjects through injury or death caused by the study. The insurance applies to the damage that becomes apparent during the study or within 4 years after the end of the study.Study ID Numbers:UnorderedList removed
: Not applicable.
: The authors declare that they have no competing interests.
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