Footnotes

• 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.