I am curious about the open label trial design. Was the decision to keep the administration of systemic alteplase open label intended to simulate expected clinical delays in regards to combination therapy? While there were several expected delays (consent, counseling, cost, administration), groin puncture time was only delayed by five minutes. When the difference between onset of symptoms to randomization is included, the difference between the two groups increases to 15 minutes. Were there differences in hospital protocol and patient safety monitoring in those who received alteplase versus those who did not?
Thank you very much for your time.
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