Maintaining Study Integrity While Ensuring Patient Safety
Due to the COVID-19 pandemic, we have made some changes to maintain the integrity of this important study, while making sure that patient safety is our first priority.
1) For patients that had visits cancelled during this period, the visits will be done remotely. You should receive communication directly from your site about when this will happen.
2) For Visits 3 and 4, we have extended the window by 3 months to allow these visits to be rescheduled when sites reopen. Your Site Coordinator will be in contact with you about when these will be rescheduled.
3) As we mentioned in our last newsletter, we are determining if we will add another visit at 24 or 30 months. We will make this decision once we have completed our interim data analysis in June, and update you all.
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