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This case was treated as a dropout because of a protocol violation.
One patient did not complete the first cycle because of a protocol violation.
We excluded one placebo-treated patient from the intent-to-treat analysis (n = 29) because of a protocol violation.
Three subjects discontinued because of an AE, one discontinued because of a protocol violation, and one discontinued by choice.
Because of a protocol for the follow-up of duodenal adenomas, a FDG-PET scan was made.
Procedural data were missing for one patient in the ultrasound group because of a protocol violation, resulting in no recording being made.
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After review of full-text, 1 was excluded because it was a publication of a protocol, 3 were excluded because they were in dialysis or end stage renal disease patients and 5 were excluded because of use of active vitamin D or analog or calcidiol.
The scope of this study was limited because of a restrictive protocol.
As discussed above, we may have underestimated the sensitivity of the Dräger Alco-Check because of a suspected protocol violation.
Three patients in Group A (two never received chemotherapy and one because of a major protocol violation) and four patients in Group B (two never received chemotherapy, one was treated with RT because of superior vena cava syndrome and one for a major protocol violation) were not evaluable.
Because of an obvious protocol violation by one center (Carrara), a sensitivity analysis was also performed excluding protocol violations (i.e., as treated per protocol).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com