Received: 22 October 2020
Accepted: 27 May 2021
First Online: 21 June 2021
Ethics approval and consent to participate
: The study adhered to and was conducted according to the principles of the Declaration of Helsinki and current good clinical practice guidelines. The protocol was approved by the responsible ethics committee of the canton of Zurich, Switzerland (KEK-ZH-Nr. 2014-0374) and the national regulatory authority Swissmedic (2015DR1009) and was registered at ClinicalTrials.gov (NCT02528526) before study start. All patients provided written informed consent before study participation, including consent for publication of individual anonymized data.
: C.N. is co-founder, director, and member of the scientific advisory board of NormOxys ®, Inc. and J.-M.L. is co-founder and chairman of scientific advisory board of NormOxys ®, Inc, this being the company that holds the patent on ITPP. M.A.S., P.L., R.G., B.H. and P.-A.C. had access to raw data. The study drug was provided by NormOxys ®, Inc, free of charge. Neither NormOxys ®, Inc nor any other funding source were involved in study design, patient recruitment/care, data collection, analysis/interpretation, or manuscript writing. The remaining authors declare no competing interests.