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However, its effectiveness needs to be evaluated in multicenter clinical trials, as recommended by the United States Food and Drug Administration FDAA), in a way similarly to what is done with drug substances.
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We comment here on the peptide P140 able to delay the development of lupus in mouse models that spontaneously develop the disease and that has been evaluated in multicenter double-blind phase IIb clinical trials including lupus patients.
High-frequency ventilation is currently an experimental alternative to conventional ventilation that likely improves oxygenation; outcome benefits will be evaluated in the multicenter Oscillation for ARDS Treated Early (OSCILLATE) trial (NCT01506401).
Ideally, a CRM training should be evaluated in a large multicenter trial [ 28].
Obviously, our results must be evaluated in a prospective and, ideally, multicenter study including more patients.
Study Design: A total of 412 patients were evaluated in a multicenter, retrospective study.
The activity and toxicity of topotecan were evaluated in a multicenter Phase II study for patients with previously treated squamous cell carcinoma of the uterine cervix.
The potential of Apligraf® (Graftskin) (Organogenesis Inc., Canton, MA), to improve cosmetic and functional outcomes when applied over meshed split thickness autografts was evaluated in a multicenter, randomized within patient controlled clinical trial.
The 6-plasmid DNA/rAd5 vector prime-boost combination has recently been evaluated in larger multicenter, international studies.
This issue has been evaluated in a multicenter phase II clinical trial (Clinical Trials NCT00974259).
Therefore, in this study both the efficacy and safety of such a regimen were evaluated in a multicenter clinical trial.
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