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These 11 patients were treated as protocol deviations Significant reductions in weekly UI episodes were observed with onabotulinumtoxinA 200U and 300U within the anticholinergic user and non-user subgroups (P ≤ 0.05 vs placebo for both subgroups; Fig. 6a).
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Therefore, we analyzed treatment failure on intention to treat as well as per protocol basis.
Intention to treat, as well as per protocol, and incremental cost-effectiveness analysis will be performed.
Statistical analysis will be based on intention to treat, as well as per protocol and safety analysis.
The required sample size incorporates a 20% inflation factor to allow for a sufficiently large dataset to evaluate the intervention based on both the intention to treat as well as the per protocol population.
If this occurred, the study would be stopped and events treated as per protocol for management of neonatal sepsis in the Department of Paediatrics.
However, for a proof-of-concept trial in which comparisons of patients treated as per protocol was of the greatest interest, we think it unlikely that this was an important source of bias.
Infection was treated as per protocols from the Department of Obstetrics and Gynaecology.
Rates of non-fatal ischaemic stroke in patients treated as 'per-protocol' from two of the three studies were also abstracted and pooled.
Safety evaluations will be performed for all patients receiving at least one dose of study drug (safety analysis set) and efficacy analyses will be performed in patients treated as per-protocol.
Nonetheless, when packaged together and treated as a statistical protocol, these methods can serve as an important new tool, which can be applied to a variety of datasets and organizational levels.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com