Bioelectronics Corp (BIEL)

[srinsocal]

A couple of questions on, 'Pulsed Electromagnetic Fields for Postoperative Analgesia', for our Clinical Trials experts:

1) There are numerous 'Quality Control' warnings posted on this Study. Can the Study results be trusted before the QC is finished?

Quality Control Review Has Not Concluded
Note: The results information displayed below has not completed the quality control (QC) review process. ClinicalTrials.gov must post results information for applicable clinical trials (ACTs) within 30 days of submission, even if the submission has not completed the QC review process. The study sponsor or investigator is responsible for ensuring the results information meets the QC review criteria.

Quality Control Review Comment provided by the National Library of Medicine:
The description of the scale or categories does not include sufficient information to understand the results reported.

Quality Control Review Comment provided by the National Library of Medicine:
The Document Type or Document Date appear inconsistent with information in an uploaded study document.
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Why was there such a large difference in Female vs Male patients between the 2 groups? Is gender not considered a factor that requires parity in this Study?

Active PSWT Female = 34 (57.6%) .......... Sham Treatment Female = 44 (73.3%)
Active PSWT Male = 25 (42.4%) .............. Sham Treatment Male = 16 (26.7%)