This was mmy question to IR, herewith their reply:
"In both countries, Italy and Israel we have initially treated/planned to treat patients on a compassionate use basis, however once we started the global Phase 2/3 study, we have added Italy (click here for the PR announcing the conversion from compassionate use to clinical trial) and Israel as part of the global clinical trial and patients are being treated there in a controlled clinical trial setting now. The results of the those patients will be announced as part of the planned top-line results in Q2/21.