J.B.: Implemented the trial.
YdR, JND, GA and MP collaboratively developed the design and implemented the trial.
CL implemented the trial protocol, managed the trial, performed blinded outcome assessment and data entry, and drafted the manuscript.
F-V initiated the collaborative project, designed data collection tools, implemented the trial, monitored data collection for the whole trial, analyzed the data, and drafted and revised the paper.
ML jointly conceived the study with DL, performed literature review, designed and implemented the trial, obtained ethics approval, have been involved in the recruitment of subjects, review of trial patients, data collection, and preparation of the manuscript.
C-FB initiated the collaborative project, designed data collection tools, implemented the trial, monitored data collection for the whole trial, analyzed the data, and drafted and revised the paper.
This paper describes the design of the trial, and discusses the rationale underlying aspects of the design and the challenges faced in designing and implementing the trial.
This article presents the study design, discusses the challenges we have faced in implementing the trial, and describes our preliminary experiences.
BG contributed to implementing the trial and overseeing all stages.
Implementing the trial design has a number of challenges.
A Project Implementation Team has also been formed to implement the trial in accordance with the trial protocol.
