Ethics approval and consent to participate
The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Medical Ethics Board and Institutional Review Board at Soroka University Medical Centre, Be’er Sheva, Israel (SOR-0280–16). Participants provided written informed consent and received no compensation.This trial was registered at ClinicalTrials.gov (NCT03020186). The research was conducted in strict compliance with the Helsinki Declaration.