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The latter was not possible because patients randomized to different study arms within the same practice would have lead to contamination of treatment effect.
Because patients randomized to CR remained in the active treatment phase notably longer than patients allocated to CH, a direct comparison of the incidence of adverse events has to be conducted carefully.
In fact, in 2004, two cancer prevention trials [ 18- 20] were terminated prematurely because patients randomized to the COX-2 inhibitor arms experienced more CV events compared to patients given placebo.
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This interpretation, which remains entirely speculative as treatment employed following removal from this study was not routinely collected as part of the study design, concludes that the PLD study arm "won" largely because more patients randomized to this regimen were able to receive the single most active drug in the malignancy, a platinum agent.
Because the total number of patients randomized to placebo was N=407, this yields an "ITT-like" placebo proportion of 46/407=11.3%.
This is because there was a clear difference in illness severity in patients randomized to CVVHF.
In that study, however, five patients randomized to IHD were excluded from analysis because IHD could not be completed due to severe haemodynamic instability.
19 patients randomized to the cases group were subsequently excluded because of protocol adherence issues (poor echographic windows did not consent adequate vena cava diameter measurement).
Of the 368 patients randomized to self management 58 declined before training, mostly because of a lack of confidence.
It is noteworthy that more than 30% of patients randomized to tandem transplant did not receive the second transplant81.
Overall, 28 patients randomized to receive hypothermia (HY) and 30 to normothermia (NT).
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