= Recommendations for intention to treat analysis (Hollis and Campbell, 1999) = ITT is better regarded as a complete trial strategy for design, conduct and analysis rather than as an approach to analysis alone. '''Design''' * Decide whether the aim is pragmatic or explanatory. For pragmatic trials, intention to treat is essential * Justify in advance any inclusion criteria which when violated would merit exclusion from intention to treat analysis '''Conduct''' * Minimise missing response on the primary outcome * Follow up subjects who withdraw from treatment '''Analysis''' * Include all randomised subjects in the groups to which they were allocated * Investigate the potential effect of missing response '''Reporting''' * Specify that intention to treat analysis has been carried out, explicitly describing the handling of deviations from randomised allocation and missing response * Report deviations from randomised allocation and missing response * Discuss the potential effect of missing response * Base conclusions on the results of intention to treat analysis