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The rationale for administering transfusions is based on key assumptions that efficacy is established and risks are acceptable and minimized.
However, as Authors highlight, even when efficacy is established, there are unknown risks following repeated application on the long run, especially on epidermal innervation.
Phase 3 risk can be mitigated by ensuring that clinical efficacy is established before initiating confirmatory trials, but traditional phase 2 trials in AD can be lengthy and costly.
However, unless their relative efficacy is established, there cannot be evidence-based treatment recommendations for PONV.
If noninferiority is satisfied, efficacy is established and statistical superiority may then be queried and demonstrated.
It also highlights the difficulty in performing subsequent trials with new agents once proof of efficacy is established.
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If longer term safety and efficacy are established among heterogeneous cohorts, these medications may help mitigate potential morbidity and mortality for this burgeoning patient population.
In-vivo efficacy was established using both ASTM E1174 and EN 1500 methods.
For navigating the regulatory process the reported results were helpful and positive: both safety and efficacy were established.
Efficacy was established after systematic review of both outpatient pulmonary rehabilitation [ 12- 14] and home-based pulmonary rehabilitation [ 15- 17].
Once the RD and preliminary evidence of efficacy were established, 59 additional patients were included in the second part of the trial.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com