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(DOCX)Click here for additional data file.The authors thank Daniel Bratton for his contribution to the statistical analysis and Catherine Charron for her input in the study setup and protocol development. The authors also thank all investigators and study staff. Editorial support (in the form of writing assistance, including preparation of the draft manuscript under the direction and guidance of the authors, collating and incorporating authors’ comments for each draft, assembling tables and figures, grammatical editing and referencing) was provided by Appitha Eakin, PhD, of Fishawack Indicia Ltd, part of Fishawack Health.