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In-vivo efficacy was established using both ASTM E1174 and EN 1500 methods.
Efficacy was established after systematic review of both outpatient pulmonary rehabilitation [ 12- 14] and home-based pulmonary rehabilitation [ 15- 17].
A predetermined primary endpoint benchmark (i.e., 6-month PFS rate ≥20%) for efficacy was established, below which the combination treatment was deemed not worthy of further investigation 16.
Despite the results of the HDHK pilot study, efficacy was established in a university-based research project that was delivered by highly qualified staff in a closely monitored trial.
After this in vitro efficacy was established, two topical formulations with GaCi (0.1% [wt/vol] and 0.3% [wt/vol]) were tested in a murine wound model of MDR K. pneumoniae infection.
This screen utilised an automated large particle flow cytometer (COPASTM Select) to automatically sort and distribute embryos of the right genotype into wells containing food mixed with chemicals, and efficacy was established through counting the number of adults and pupae after 10-15 days. 10-15 days
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The rationale for administering transfusions is based on key assumptions that efficacy is established and risks are acceptable and minimized.
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.
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, as Authors highlight, even when efficacy is established, there are unknown risks following repeated application on the long run, especially on epidermal innervation.
If noninferiority is satisfied, efficacy is established and statistical superiority may then be queried and demonstrated.
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CEO of Professional Science Editing for Scientists @ prosciediting.com