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However, one international organization has documented as of 2011 34 pages of clinical trial study data and reports of the plant and its products attesting to its efficacy and safety with no attributable major toxicity or mortality.
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This analysis is one of the first in Nigeria to assess long-term outcomes of pediatric HIV care and uses routine program real-world data as opposed to trial or study data.
This is a single-arm, open phase II trial comparing the study data to historical controls.
E Bortey contributed to clinical trial study design, analysed data and critically reviewed and edited the manuscript.
Author contributions: Dr Schoenfeld contributed to clinical trial study design, analysed data and wrote and edited the manuscript.
WP Forbes contributed to clinical trial study design, analysed data, and critically reviewed and edited the manuscript.
The National Institute of Health NIHH) considers studies that reuse clinical trial or observational study data to be sufficiently desirable and common that it provides numerous, ongoing grant mechanisms [ 2- 9] for funding them.
Dr Pimentel, Dr Chang, Dr Lembo, Dr Chey, Dr Yu, Dr Bortey and Dr Forbes critically reviewed the clinical trial study design, analysed data and critically reviewed and edited the manuscript.
All evaluated studies were retrospective analyses of randomized controlled trials or observational study data.
The DSMB will provide independent oversight of the PODCAST trial and will review the general conduct of the trial as well as study data for participant safety.
Articles were stratified on evidence strength dependent on study design, which included systematic reviews, randomised controlled trials (RCTs) and cohort study data.
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CEO of Professional Science Editing for Scientists @ prosciediting.com