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One patient also had a non-index lesion that did not meet the protocol defined criteria for cure.
For the two patients in the WR 279,396 group whose index lesions did not meet the protocol criteria for cure, one index lesion failed because it never re-epithelialized and one index lesion failed because of relapse.
One treatment-naïve patient with cirrhosis had a quantifiable HCV-RNA level of 53 IU/mL at end of treatment; this event did not meet the protocol definition of VBT, which required on-treatment confirmation of the HCV-RNA measurement.
In some regions, however, data on women's personal variables were either not routinely gathered or data collection did not meet the protocol's requirements before the specified date.
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Does the traveller's cheque meet the protocols?
Schools that could not meet the protocols were not allowed to open.
Objective RR was 21% (4 of 17 patients with measurable disease; 95% CI: 3 39%), and because we could not meet the protocol-defined precondition of 30% RR, the study was stopped.
Several of these companies then obliged us with demonstrations of how their equipment could meet the protocols.
One respondent deferred to policies rather than individual decision-making, suggesting "I am not sure if there is much of a decision because there are protocols in place so if they meet the protocols they get the test".
Following the meeting the protocol was approved for implementation.
Analyses in a 'per protocol set (PPS)', the population meeting the protocol criteria, were also performed.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com