Background
Introduction
Mechanisms
Existing knowledge
Hypothesis
Need for a trial

Dose selection

Summary

Trial Size
Estimated event rate
Size of treatment effect that should be detectable
Sample size
Effects on other outcomes

Eligibility
Inclusion criteria
Exclusion criteria
Special eligibility considerations
Eligibility graph

Consent

Randomisation

Study Treatment

Serious Unexpected Suspected Adverse Events (SUSAR)

Expected side effects

Unblinding

Measures of Outcome
Primary outcome measure
Secondary outcome measures
Data collection
End of trial for patients

Analysis

Steering Committee

Data Monitoring Committee

Collaborators' Responsibilities

Co-ordinating Centre Responsibilities

Publication

Indemnity

Financial Support

References

Patient Entry Form

Outcome Form

Patient and Relative Information Sheet

Legal Representative Consent Form (EU)

Procedure for obtaining Consent (EU)

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