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Although it appeared to be beneficial in the above-mentioned trial in Guinea-Bissau, researchers at Kintampo HDSS in Ghana found no positive effect of vitamin A supplements in combination with vaccines during the first few months of life (68).
The inadequacy of using HPV infection as the primary endpoint for efficacy in women over age 26 years is underscored by the refusal of the US Food and Drug Administration to grant approval for the quadrivalent vaccine for women aged 27 45 based on data from the above-mentioned trial of women up to age 45 years (Roberts, 2011).
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The apparent discrepancy in rate of virologic failure between the above-mentioned trials and our trial may be related to a different definition of virologic failure [11].
Although diarrhoea was reported in ∼60% of the 55 patients receiving octreotide or lanreotide in the two above-mentioned trials, steatorrhoea developed in only one of them [ 1].
Unfortunately, the important clinical question of whether there was any gain in adding goserelin to tamoxifen was not addressed in any of the above-mentioned trials.
Treatment site reactions were similar for Juvéderm™ Ultra Plus and Zyplast® and were similar to those in the above-mentioned trials.
Using a KLH-coated column (Alpha Diagnostic International, San Antonio, TX, USA), 18 ml starting serum pool of KLH-specific Abs was isolated from the above-mentioned trials.
Recently, a meta-analysis of PFS and OS data from the three above-mentioned trials (E2100, AVADO, RIBBON-1) including 2,447 patients has been published.
In general, these above-mentioned trials have shown some activity of tyrosine kinase inhibitors in MBC, although results have been heterogeneous.
In the years following the closure of the above-mentioned trials, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and Global Advocacy for HIV Prevention (AVAC) initiated the development of a set of guidelines for good participatory practice (GPP) in biomedical HIV prevention trials [ 8, 9].
76, 77 In the above-mentioned trials, the percentage of severe (Class III/IV) congestive heart failure, or cardiac-related death for patients receiving trastuzumab ranged from 0% (59) to 4.1%.
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