3.1. Study Population and Design
The study was conducted from June 2018 to January 2019 and was approved by the local Medical Ethics Committee of the Maastricht University Medical Centre + and performed in accordance with the Declaration of Helsinki of 1975, as amended in 2013, and with the Dutch Regulations on Medical Research involving Human Subjects from 1998. All participants gave written informed consent before data collection. The study was registered at clinicaltrials.gov as NCT03781999. The detailed design of this research containing CONSORT flow diagram of the study participants was previously described by Ahles et al. [