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These trials include very heterogeneous patient groups and the mean values may disguise huge individual variability.
The generally accepted inclusion and exclusion criteria for these trials include adequate organ function and reasonable PS in order to ensure safety and avoid unnecessary toxicity.
In short, these trials include the Scandinavian GLN trial [ 39], which examined 413 patients in multiple centers and demonstrated a benefit on ICU survival rates with parenteral GLN.
Outcomes measured in these trials include absolute and percentage weight loss; change in waist circumference; changes in serum cholesterol levels, glycemic parameters, blood pressure, and metabolic syndrome status; quality of life; and safety and tolerability.
Other limitations of these trials include resuscitation protocol complexity, potential risks associated with elements of the protocol (especially the use of dobutamine and red blood cell transfusions), and financial and infrastructure implications necessary to carry out these protocols.
Recommendations from across these trials include participant-centered approaches, separating measurement of adherence from adherence counseling, incorporating tailored strategies that go beyond education, fostering motivation, and addressing the specific context in which an individual incorporates and negotiates PrEP use.
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These trials included 679 unique families with many of the families established at more than one trial site.
However, none of these trials included patients with lymph node invasion (LNI).
These trials included two alkaline salts (Na2CO3 NaHCO3; 1:1, v:v) that were intended to simulate soil conditions in northern China.
Traditionally, small seedlings have been planted out in winter (these trials included) but planting in late spring is likely to improve survival.
MVA85A is now in clinical trials in the UK and Africa and the design of these trials, including the ethical and regulatory issues are discussed.
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