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Tuesday, July 09, 2024 11:13:59 AM
https://clinicaltrials.gov/study/NCT05399355?tab=history&a=9#version-content-panel
Some results are WORSE for the active device. That's the risk of small sample sizes.
Example: Primary category 3, Total opioid consumption from day 1 through day 7: (this is the most important category for opioid use)
Mean (Standard Deviation) | Unit of Measure: mg: active 21 (24), sham 17 (26)
The secondary opioid categories are 28-32. Opioid use was higher for the active device in every category except 30, (day 3, they were the same) and 31 (day 7, slightly lower for active device).
Interpret this for yourself. I'm not going to say more. Maybe the columns are mislabeled. Let's hope.
Note that these results are not broken out into indications, of which there were many. For the SofPulse study that Ilfeld started about halfway through the ActiPatch study, Ilfeld cherry-picked three of the indications. It certainly looks to me like he examined these results midway through the study and noticed better performance for certain indications.
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