INS and diabetes mellitus: The TRIGR (Trial to Reduce Insulin-Dependent Diabetes Mellitus in the Genetically at Risk) study was cited as a good example of “arm’s length” BMS trial practice, in which the BMS manufacturer’s role was limited to provision of trial interventions.26 Experts also emphasized that significant trial amendments—especially changes to participant inclusion criteria, experimental or control treatment, and methods, timing, or nature of outcome measures—should be recorded by way of an update to the BMS trial’s record on a World Health Organization–approved clinical trial registry.