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Unfortunately we cannot process your manuscript further until you attend to the following point:
- The methods section must include a subsection that describes the methods used for statistical analysis (see the section on statistical analysis in the Appendix) and the sample size must be justified by the results of appropriate calculations and related to the study outcomes.
Justification of sample size: All manuscripts that report primary research must contain a statistical justification of sample size that is stated explicitly in the Statistics sub-section of the Methods. Manuscripts that do not contain this information will be rejected automatically and returned to the authors for correction. The revised versions will be treated as new submissions. The information required must include, but not be restricted to, the following:-
• Hypothesised effect size with appropriate justification.
• A statement regarding statistical power (typically 80%) and the two-sided significance level (typically 0.05).
• An explanation of how the statistical power was calculated.
• If sample size is determined by the feasibility of recruitment minimally detectable effect sizes should be provided instead of power analysis.
The only exceptions are:-
• Meta-analyses.
• Exploratory or secondary analysis of observational studies based on large sample sizes
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