Reporting random controlled trials

Please define the methods and support them with references, describing in detail any that are not in common use.

General guidelines on using statistical methods and interpreting and presenting statistical material, as well as specific recommendations on statistical estimation and significance, have been published in the LJPC.

Randomised Controlled Trials

Please report these in accordance with the CONSORT (Consolidated Standards of Reporting Trials) statement.

This ensures that you provide enough information for editors, peer reviewers, and readers to see how the trial was performed and to judge whether the findings are likely to be reliable.

Please provide the following, as described in the CONSORT statement:

• Five extra subheaded sections in the main text of the paper: protocol, assignment, masking, participant flow and follow up, analysis
• A flow chart (fig 1) showing the progress of participants through the trial
• A checklist for editors and reviewers (not for publication) showing that you have described 21 key points in your report

We may choose not to use all of the subheadings in the published version of the paper for reasons of readability.