Shoer, Saar http://orcid.org/0000-0003-0883-1434
Shilo, Smadar http://orcid.org/0000-0003-2399-1866
Godneva, Anastasia
Ben-Yacov, Orly
Rein, Michal
Wolf, Bat Chen
Lotan-Pompan, Maya
Bar, Noam
Weiss, Ervin I. http://orcid.org/0000-0001-8639-9507
Houri-Haddad, Yael
Pilpel, Yitzhak
Weinberger, Adina http://orcid.org/0000-0003-2231-4687
Segal, Eran http://orcid.org/0000-0002-6859-1164
Article History
Received: 23 February 2023
Accepted: 17 August 2023
First Online: 4 September 2023
Competing interests
: The authors declare no competing interests.
: Clinical trial registration number NCT03222791, ExternalRef removed. The study was approved by the Institutional Review Board (IRB) ethics committee of the Weizmann Institute of Science (reference number: 398-1) and by a sponsor-appointed data and safety monitoring board. Trial registration with ClinicalTrials.gov occurred on 13/07/2017, a few months after recruitment started because of technical and administrative reasons, but only 17 of the 225 participants were recruited during this period. The other 208 patients were recruited after trial registration. Importantly, the study design and protocol were set, finalized and approved by the institutional review board committee and the sponsor-appointed data and safety monitoring board before the trial start and before the first participant was enrolled. All participants signed the informed consent of this protocol. Exploratory analysis was not pre-specified in the study protocol.