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WZ assisted with the drafting of data collection instruments and other materials as well as data analysis and interpretation.
Clinical management meetings: JL and WEH, CDA, SD, JAD and JPN assisted with ongoing conception and design, drafting of data collection instruments and other materials and assisted with data analysis/interpretation.
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PW participated in study design, edited drafts of data collection tools and was integral in drafting and revising the manuscript critically for important intellectual content.
BOH was responsible for the design, drafting, analysis of data, and drafting and editing of the manuscript.
PB helped with drafting, acquisition of data and revision.
J.A.B., M.M.A. and P.J.H.: drafting, interpretation of data and revision of manuscript.
AE analyzed the data and contributed to the drafting of the data.
JC: Participated in the design and drafting of the data analysis plan in the protocol.
PR: Participated in the design and drafting of the data analysis plan in the protocol.
DA: interpretation of data, drafting of manuscript.
SM recruitment of subjects, analysis and interpretation of data, drafting and revision of manuscript.
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