2 results
Approved WMOCompleted
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
Approved WMORecruiting
The device, the cardiac arrhythmia software, is intended to record, store and analyze the heart rate data collected by a PPG sensor to provide the user with notifications of events that indicate an irregular heart rhythm. The information is not…