Stopping Criteria. Given the uncontrolled nature of the study, and the small sample size, it is not practical to provide a quantitative stopping rule. Moreover, given the severely ill nature of the patients who will be enrolled in the study (those with large myocardial infarction and substantial LV dysfunction), adverse cardiac outcomes, including fatal ones, are to be expected in this population, regardless of participation in the study. The study will be stopped when any of the following occur:
Appears in 7 contracts
Samples: License and Commercialization Agreement (Bellerophon Therapeutics, Inc.), License and Commercialization Agreement (Bellerophon Therapeutics LLC), License and Commercialization Agreement (Bellerophon Therapeutics LLC)
