Ethics
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Clinical trial registration NCT04661930.Human subjects: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. In the observational studies - the Israeli study was approved by the local institutional review board of the Hadassah Medical Center (IRB approval number no. HMO 0247-20) and the local institutional review board of the Ichilov Medical Center (IRB approval number no. 0282-20-TLV). The Italian study was reviewed by the local ethical board (AVEC) of the IRCSS S.Orsola-Malpighi University Hospital (approval number no. code LLD-RP2018). The American study was reviewed by the local institutional review board of the Corporal Michael J. Crescenz VA Medical Center (IRB approval number 01654). The interventional study was conducted in accordance with the Good Clinical Practice guidelines of the International Council for Harmonisation E6 and the principles of the Declaration of Helsinki or local regulations, whichever afforded greater patient protection. The study was reviewed and approved by the Barzilai Medical Center Research Ethics Committee (0105-20-BRZ). Statistical analysis of the Israeli studies was done by BioStats Statistical Consulting Ltd. (Maccabim, Israel), funded by the sponsor. Data management is performed in compliance with GCP and 21 CFR part 1. Statistical analyses and reporting are performed in compliance with E6 GCP, E9, and ISO 14155. Independently validated by the author. Statistical analysis of the Italian study was done by Prof. Arrigo Cicero and Dr. Chiara Pavanello. Statistical analysis of the US study was done by Prof. Jordana Cohen.