CONSORT 2010 checklist of information to include when reporting a randomised trial*.
(DOC)Click here for additional data file.(DOCX)Click here for additional data file.(DOCX)Click here for additional data file.We thank Mr Rabii Razgallah for his assistance during redaction of protocol and made available to us DACIMA platform.We thank Mrs Marwa Naimi for revising the English of the manuscript.