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Eligibility criteria relate to the external validity of the study, assisting the clinician to decide whether the results of the trial can be applied to his own patients.
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MMM conceived of the study, assisted with the research design, data analysis, and writing the manuscript.
RH helped design the study, assisted with the patient recruitment and contributed to the writing of the paper.
SDC conceived the idea for the study, assisted with the data analysis and writing of the manuscript.
BDXL helped to plan the study, assisted in data collection, performed data analysis, and participated in manuscript preparation.
BE is project manager of the study, assisted by EvdP.
MO initiated and organized the study, assisted by JS.
PB helped conceive the study, assisted in the study design and interpretation of the data.
CEW conceived of the study, assisted in the analyses, and assisted in writing the manuscript.
KMC and KGF assisted in methodology of the study, assisted in data analyses, edited the manuscript.
UR designed the study, assisted the statistical analysis and helped to draft the manuscript.
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