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DM was the Principle Investigator and responsible for data collection and coordinating study procedures.
To initiate the study, the monitor visited each participating local trial site and coordinating study centers.
Information on allocation is only accessible to the study personnel at the coordinating study centre in Maastricht; patients will receive information about their allocation via the coordinating study centre.
The interventionist scheduled treatment sessions, faxed records to the distant coordinating study centre and kept all documents strictly separated from any other site staff.
A random sample of 40 patients will be selected by the coordinating study team (from an anonymised list) and approached en bloc by the research nurse, to obtain a target sample of 30 recruited patients per clinic.
To evaluate the concordance of patient and proxy/family responses a second survey measure will be offered to eligible family members of participating patients (administration of second surveys restricted to coordinating study site).
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RM helped conceive, design and coordinate study.
KH conceived and coordinated study and drafted the manuscript.
SJD planned and coordinated study and drafted manuscript.
Both Logan and John have coordinated study-abroad programs for Americans studying Chinese.
MJD and CG-E coordinated studies.
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