Results of this trial will be published in a peer-reviewed journal. The abstract will be submitted for presentations at different congresses. Within 6 months of completion of the trial, the ClinicalTrials.gov site will be updated to include summary results.

Authorship is granted to authors who make important contributions to the creation of the final publication in accordance with recommendations from the International Committee of Medical Journal Editors and GIRCG group internal policy. Authors can contribute via written or physical help in this clinical trial.

The datasets used during the current study will be available from the corresponding author on reasonable request within 1 year after completion of the trial.

A timeline of the overall study design is displayed in Fig. 4.

Overall timeline of the study

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