Funding for this research was provided by:
Received: 16 July 2020
Accepted: 5 August 2020
First Online: 26 August 2020
Ethics approval and consent to participate
: Ethical approval by the Ethics Committee of the Medical Faculty of the University of Heidelberg was obtained (AFmu-683/2019 March 18, 2020). Before participation in the clinical study, written informed consent will be obtained from each subject. Furthermore, the DEGRO expert panel reviewed the radiation regimen to rule out that permission of radiation administered would have to be requested from the BfS (Federal office of radiation protection; “Anfrage 167 / 09 July, 2019”). Additionally, the Paul Ehrlich Institute (competent authority for approval of clinical trials using medicinal products for human use in Germany) approved the study (no. 3881/02, March 10, 2020).
: Not applicable, as no individual patient data are contained in this manuscript.
: The TRADE-hypo trial receives funding from AstraZeneca/ MedImmune. However, AstraZeneca/ MedImmune has not been involved in study design, data collection, management, data analysis and interpretation, or in the decision to submit this protocol for publication. All authors declare that they have no competing interests.