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Therefore, PCT-guided algorithms to reduce the duration of antibiotic therapy can be used safely in immunocompromised patients, to the exception of neutropenic patients (<500 neutrorhils/mm3) or bone marrow transplant recipients, which were excluded from trials and in whom PCT-guided therapy cannot be recommended.
Therefore, PCT-guided algorithms to reduce the duration of antibiotic therapy can be used safely in immunocompromised patients, to the exception of neutropenic patients (<500 neutrophils/mm) or bone marrow transplant recipients, which were excluded from trials and in whom PCT-guided therapy cannot be recommended.
Extensive and properly carried out and thought-through sensitivity analyses may help to extrapolate the study findings to those who were excluded from trials, who in many cases are the bulk of the patients considered for that specific intervention in the real clinical non-experimental world.
The trial data largely precede the widespread use of proton pump inhibitors (PPIs) or Helicobacter pylori eradication therapy; patients with a history of peptic ulcer were excluded from trials of LDA, and the results of these trials may not be readily applicable to patients who take PPI drugs with LDA.
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Patients who met any of the criteria (listed above) at the screening visit were excluded from trial participation.
In the AFFIRM trial, patients with a history of seizures or with other risk factors for seizures were excluded from trial entry.
A further review of the data indicates that 72% (13/18) of the ineligible breast patients were excluded from trial entry because they had received too much prior treatment.
Historically, they have been completely absent: the thalidomide scandal of the early 1960s resulted in women of childbearing age being excluded from trials.
Nevertheless, until the nineties children kept being excluded from trials just to safeguard their vulnerability [ 4].
There are also implications of the high prevalence of comorbidities to clinical trial design in people with CKD (where people with comorbidities may be excluded from trials).
With the introduction of targeted treatments and the proliferation of clinical studies, patients whose grade has not been correctly evaluated may be excluded from trials [ 20- 23].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com