The Background section should explain the background to the study, its aims, a summary of the existing literature and why this study is necessary or its contribution to the field.
The methods section should include:
- the aim, design and setting of the study
- the characteristics of participants or description of materials
- a clear description of all processes, interventions and comparisons. Generic drug names should generally be used. When proprietary brands are used in research, include the brand names in parentheses
- the type of statistical analysis used, including a power calculation if appropriate.
This should include a discussion of any practical or operational issues involved in performing the study and any issues not covered in other sections.