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The authors do not have a comparison between those who tried one versus two versus three or more preventive treatments prior to OnabotulinumtoxinA but such an analysis will be performed as these data will become available.
Such an analysis will be performed in the near future to confirm the effectiveness of our cell therapy.
Additionally, such an analysis will be performed incorporating imputation, whereby pretest member data will be carried forward in instances where post-test data are missing for clubs.
An analysis will be performed first to compare the mean HSBP readings in phase 1 and 2 between combination therapy and monotherapy.
An analysis will be performed to check whether adjusting for age and sex (the stratifiers) in the analysis of covariance model has any impact on the estimated treatment effects; if it has no impact, then they will not be included in the model.
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Additionally, as a secondary analysis, a responder analysis will be performed according to the cut-off values as proposed by a consensus panel [ 50].
After inclusion of 20 patients an interims analysis will be performed.
Following completion of imaging at 6 months, an interim analysis will be performed.
After 900 inclusions, an interim analysis will be performed on safety.
One year after inclusion of the first patient an interim analysis will be performed.
After the inclusion of 20 patients an interims analysis will be performed.
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