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The statistician will be unaware of group allocation until completion of data analyses.
At the completion of data analyses, each participating health region will receive feedback on their clinic's performance, relative to other similar health regions.
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ZY drafted the manuscript and contributed the design and completion of the data analyses.
Following completion of data collection, analyses will proceed in two steps using a mixed effect "random regression" (RR) model.
Recruitment will continue until sample size is reached followed by completion of data collection and analyses.
Following completion of data collection, we created a secure collaborative workspace for investigators involved in ICARE data analyses, with access to a central relational database, scans of the questionnaires, data dictionary, meeting minutes, and various documents.
Data analysis will be undertaken at the completion of data acquisition and will be by intention to treat (that is, participants will be analysed according to group allocation regardless of compliance) [ 60].
All analyses were conducted in a blinded fashion and investigators were unblinded to treatment/genotype following completion of data analysis.
Breaking of the blinding took place only after the completion of all examinations and data analyses of the individual patients.
Month 27-43: Completion of data collection.
Month 13 24: Completion of data collection.
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