Authors’ contributions
MP
CK is the principal investigator for the study described in the manuscript. MP and CK are responsible for the concept and design. MP, JF, MD, and CK made significant contributions to protocol validity, design, drafting, and revising of the manuscript. AK developed the statistical considerations for the trial. ORM, UN, SK, and CP contributed to the scientific accuracy of the manuscript. CK and JW gave the final approval for the final version to be published. All authors read and approved the final manuscript.