Unblinding Unblinding of the participants will be permissible under the following circumstances: treatment of a participant in a medical emergency that requires knowledge of treatment allocation, treatment of a participant for an adverse event (AE), in the event of a suspected unexpected serious adverse reaction (SAR), and SAR is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly or birth defect
The SUSTAIN-6 trial, which evaluated semaglutide in patients with type 2 diabetes at high cardiovascular risk, identified a statistically significant increase in diabetic retinopathy complications in the semaglutide group compared to placebo
All authors had full access to the data, and all authors had final responsibility for the decision to submit for publication
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