Stefan P. Hicklin

Aug 15, 2023 | mdpi.com | Malin Strasding |Yuwon Jeong |Laurent Marchand |Stefan P. Hicklin

2. Materials and MethodsThe present study was performed according to the Declaration of Helsinki on medical protocol and ethics, in compliance with ICH-GCP guidelines and ISO 14155, and the CONSORT guidelines for randomized trials. The study was registered in the US clinical trials register (NCT05079542) on 15 October 2021. The protocol was approved by the respective local ethical committees (CCER 15-117).