Division 4 F1

Abstract: stand-alone summary of the study protocol, including the following subsections:

1. (a)

   title with subtitles including version and date of the protocol and name and affiliation of the main author;

2. (b)

   rationale and background;

3. (c)

   research question and objectives;

4. (d)

   study design;

5. (e)

   population;

6. (f)

   variables;

7. (g)

   data sources;

8. (h)

   study size;

9. (i)

   data analysis;

10. (j)

    milestones.