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Although it is likely that these numbers can be improved somewhat, in most cases any subsequent analysis will be much more computationally expensive.
However, as long as full phenotypic rescue is achieved after reintegration, one can be confident that the subsequent analysis will be physiologically relevant.
Interactions with ethnicity will be examined and if an interaction with ethnicity is identified, all subsequent analysis will be stratified by ethnicity (South Asian vs White British).
The modeling framework and subsequent analysis will be similar to that for BFI with the phase variable replaced by a continuous week variable.
Subsequent analysis will be confined to controlled mechanical ventilation and it needs to be emphasized that hemodynamic effects during assisted spontaneous ventilation, compared to controlled ventilation, may be substantially different due to the difference in ITP.
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All subsequent data analysis will be performed without interaction with the patient.
A web-based tool developed for the CTA study 14 to enter data during MRR and subsequent data analysis, will be modified to include the CTK paediatric conditions and indicators.
Such detailed analysis will be conducted in subsequent studies.
Trials conducting 'as observed' or 'per protocol' analysis will be excluded from subsequent analysis stages (8a-9b, figure 2) as they do not assess missing data or withdrawal patients, per se.
To avoid bias in the subsequent trial, the results of the interim analysis will be treated confidentially and will not be communicated to the outside or to the clinical investigators involved in the trial.
More detail on the causal network analysis will be described in a subsequent publication.
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