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NG and EEH contributed equally.
Contributors NG, EEH: acquisition of data, drafting the manuscript. MM: study design, acquisition of data. NA: study design, acquisition of data, critical review of manuscript. JL, DS, AK, VB, YR, IG, MSL: acquisition of data.
Funding The study was funded by Check-Cap Ltd, Mount Carmel, Israel.
Competing interests NG and NA report receiving consulting fees from Check Cap Ltd.
Patient consent Not required.
Ethics approval IRB in all participating sites, as well as by the national ethics committee of the Israeli Ministry of Health.
Provenance and peer review Not commissioned; internally peer reviewed.