In addition to the primary endpoint, we are also interested in the following endpoints.
It may be useful in such studies, in addition to the usual endpoint of the time to first episode, to include end points which take into account the total number of clinical episodes experienced per child.
In addition to the secondary endpoint comparing the healthcare resource utilization for HF or LV lead surgical revision, we also determined the healthcare resource utilization for solely HF hospitalizations; this was done using the non-parametric bootstrap method.
In addition to the primary endpoint of comparing the hospitalization rates for HF or LV lead surgical revision, we also determined the hospitalization rates for (i) HF hospitalizations, (ii) hospitalizations not related to HF and LV lead surgical revision, and (iii) all cause hospitalizations; this was determined using negative binomial regression.
In addition to the primary endpoint of incidence of invasive breast cancer and ductal carcinoma in situ (DIN 1c, 2, 3) of the breast, the study is also examining endometrial cancer, clinical bone fractures, cardiovascular events, venous thromboembolic events, and clinically manifest cataracts and overall mortality.
7 In addition to the primary endpoints of CV death and hospital admission for treatment of worsening heart failure, the first secondary endpoint in PARADIGM-HF is health-related quality of life (HRQL), as assessed by the KCCQ.
In addition to the analgesic endpoints, functional measures of difficulty in swallowing and throat numbness were also assessed.
In addition to the efficacy endpoints, we assess the peripheral and central modulation of pain (quantitative sensory testing, QST, and conditioned pain modulation, CPM) in all the patients to explore the differences in pain processing induced by the EMDR intervention.
In addition to the trivial endpoints of 0 and 1, we also have the Alice-Bob boundary at 0.4 and the Bob-Carol boundary at 0.8.
Therefore, in addition to the short-term radiological endpoint, also the long-term patient relevant outcomes will be determined in this trial.
