Human subjects
All protocols involving human tissue were reviewed and exempted by The Hebrew University of Jerusalem, the Israeli Ministry of Health, Sheba Medical Center and Icahn School of Medicine at Mount Sinai Institutional Review Boards.Experiments using samples from human subjects were conducted in accordance with local regulations and with the approval of the institutional review board at the Icahn School of Medicine at Mount Sinai under protocol HS#12–00145 and the institutional review board at Sheba Medical Center under protocol SMC-7875–20.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 LLD-RP2018).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).