Safety
constipation, dizziness, pain, constipation, dizziness, neck pain
EVENTS, EVENT
There were no SAEs reported in this study and no subjects were discontinued due to AEs. During the product trial period on Day −1, during which subjects were allowed to use a single iD of their choice with the Pulze HTS, one mild AE (dizziness) was reported by one (4%) subject. The Investigator considered this event unrelated to study product use. Overall, AEs were infrequently reported in this study, with six AEs reported by five (21%) subjects after study product randomisation. Catheter site pain was reported three times by three (13%) subjects, and the remaining AEs (constipation, dizziness, and neck pain) were reported by one (4%) subject each. The constipation and dizziness events were moderate in severity, and the catheter site pain and neck pain events were mild. The Investigator considered all AEs to be unlikely related or unrelated to study product.Mean vital signs (heart rate and blood pressures) remained within normal limits at all study time points, with minimal change from baseline. There were no individual clinically significant vital sign findings in this study.