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In those patients for which the marker lesion is measurable by the grid, the mean of the total area remaining affected at 4 weeks for each treatment group will be compared using the t‐test and 95% confidence interval for the difference reported. In addition, regression analysis will verify if this comparison requires adjustment for imbalance in the baseline target lesion area values as well as its location and other clinical assessment values.

A more detailed longitudinal analysis will make use of all the individual measures (maximum 8 per patient) using the area under the curve (AUC) as the summary statistic for each patient. The mean AUC over all patients within the treatment group is calculated and then between treatment comparisons made using the t‐test. A full statistical modelling approach using generalised estimating equations (GEE) is also anticipated. However, details of this latter methodology may have to await examination of the final data available. For example, this methodology would not be appropriate if all patients achieved complete response by week 4 and all subsequent target areas were then zero.

In similar ways, the complete VAS for burning sensation profile will be summarised.