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Then, the CSH specifications and the results of the data analyses will be compared.
55 The R-code from the data analyses will be published as supplementary material.
Both research assistants who perform the measurements and the researcher who performs the data analyses will be masked.
The data analyses will be performed by following the intention-to-treat procedure (effectiveness study) and the per-protocol-procedure (efficacy study).
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All the primary data analyses will be carried out according to a pre-established analysis plan; all analyses will be done applying SAS software (v. 9.2 Service Pack 4; SAS Institute Inc., Cary, NC, USA).
The final step of data analyses will be the merging of outcome data and process evaluation.
Since the inclusions into the registry are ongoing, data analyses will be conducted repeatedly.
The results of big data analyses will be incorporated into standards and guidelines and will directly impact clinical decision making.
The statistician involved in data analyses will be blinded for treatment allocation.
However, the statistician who will be involved in data analyses will be blinded for treatment allocation.
It is not possible to blind participating FPs/GPs from the planned intervention but individuals involved with data analyses will be blinded to group allocation and initial results will be provided to researchers without revealing group allocation.
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