Ethics approval
ICH
The study was registered on clinicaltrials.gov (NCT02952911). The study was conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki. All participants provided informed consent and ethical approval was obtained from the ethics committee of the Vall d’Hebron University Hospital, Barcelona, Spain (study number: PR(AG)300/2016) and the institutional review board of the University of California San Francisco, San Francisco, CA, USA (reference number: 175728) prior to study initiation.