All trials described in this article were approved by the Institutional Review Board of the Netherlands Cancer Institute.
The incidence of hypoglycemia in various trials reviewed in this article depends on the definitions of mild, moderate, and severe hypoglycemia.
All of the trials reviewed in this article are attempting to collect substantial evidence for efficacy and safety, which is required to obtain regulatory approval (for example, by the US Food and Drug Administration).
Major parts of the CopenHeartSF methods section and trial design in this article are similar to other randomised clinical trials, Copen HeartIE 50 CopenHeartRFA 51 and CopenHeartVR.
In the trial described in this article, we introduce patient empowerment into a whole new field of care: insurance medicine.
The trial described in this article has been conducted since 2003 in the Nouna Health District, a region located in north-western Burkina Faso about 300 km from the capital Ouagadougou [ 19].
For each trial presented in this article, all parameters, except kin_HbA1c and kout_HbA1c, were estimated using a nonlinear mixed-effects approach as done for the development of the model (Table 2 ).
The proposed trial presented in this article will investigate the effects of a fall prevention exercise program developed by an expert panel on intrinsic fall risk factors (i.e., balance, strength / power), body composition, cognitive function, psychosocial well-being, and falls-self efficacy.
Challenges in recruiting American Indians and Alaska Natives into cancer clinical trials are addressed in this article.
A joint model for analyzing incomplete data from crossover trials is proposed in this article; the model includes a measurement model and an outcome dependent informative model for the dropout process.
