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Fifty four trials designated at least one outcome measure as primary in the protocol (n=49) or publication (43).
In an editorial in the journal Circulation, Loscalzo [ 7] proposed a binary classification: trials designated a priori as pilots, and those redefined a posteriori.
Previous research shows that these children can suffer moderate and severe adverse drug reactions (ADRs) in clinical trials, yet very few of the trials designated a data safety monitoring board (DSMB) to oversee the trial.
Although there is insufficient evidence to conclude whether there exists a benefit in functional status as a result of supplementation, seven of the trials designated length of stay as an outcome measure and demonstrated that nutritionally supplemented elderly patients have a shorter overall length of stay in hospital.
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The 2-year, phase III trial designated Anti-vascular endothelial growth factor (VEGF) Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization (CNV) in Age-related Macular Degeneration (ANCHOR) compared ranibizumab with verteporfin photodynamic therapy (PDT) in treating predominantly classic CNV.
This was a multicenter, randomized, parallel-group, safety-assessor blinded, phase IIIA trial, designated the Signal study (NCT00473694).
In the first trial (designated Trial A), the standard of care chemotherapy consisted of weekly administration of 5-FU and leucovorin (Roswell Park regimen); in the second trial (designated Trial B), the standard of care chemotherapy consisted of weekly or bi-weekly administration of 5-FU, leucovorin, and Irinotecan (CPT-11).
The GLUCONTROL trial designated 142 of 1,078 patients (13%) as having a neurological diagnostic category, but did not provide results for this subgroup [ 91].
29 32 In this first-in-man clinical trial, designated RSV001, we characterise the safety and immunogenicity of novel viral-vectored vaccines used to deliver RSV antigen in healthy adult volunteers.
Total RNA was isolated from PBMC prepared from patient's blood samples taken before (pre-dose day 1) and after (pre-dose day 56) administration of SU5416 or corresponding control regimen in a Phase III trial, designated as Trial A. Due to typically low RNA yields, many sample pairs were of insufficient quality for further use (failure rate of at least 1 of 8 samples, or 25% of sample pairs).
Towards the end of the preparatory period, eight trial clusters (designated "first year trial clusters") were randomly selected to receive the SHQIP in the second year.
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