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Where necessary, supplementary data will be accessed (eg, adding process evaluation or protocol papers of included studies).
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This data will be included in the supplementary data.
All data will be recorded on electronic eCRF (see figure 1; online supplementary appendix 1 shows the clinical trial assessment).
The data will be entered into a spreadsheet using a software for programmed data entry (Epidata) with in-built validity checks and error detection (supplementary file 5).
Supplementary analyses will be carried out in which data relating to compliance with the program elements is taken into account.
55 The R-code from the data analyses will be published as supplementary material.
A customised data extraction form (see online supplementary appendix 2) will be piloted on two studies not directly related to this review, and then used to extract data.
Supplementary information of primary literature deposited with journals is a rich reservoir of peer reviewed molecular data which will be more valuable if available for further reuse.
Additional material is provided in a supplementary file (Benecha et al. 2017); if permission is obtained to share the Lanarkshire trial data, it will be posted at the referenced website.
Supplementary data answering these questions will be important to provide.
Variables to be included in the data extraction form are provided in online supplementary appendix 2. The data extraction form will be piloted on a sample of 10 articles to assess completeness, usability and technical issues.
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