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Patients were followed at least every 3 months after completion of protocol treatment.
One patient in the CE arm was found to have LD after the completion of protocol chemotherapy due to protocol violation, and this patient was considered ineligible.
After the completion of protocol treatment, patients are followed-up following the same schedule as for the observation group until recurrence, other malignancy or death is confirmed.
Following completion of protocol chemotherapy, patients were followed-up 2-monthly for the first 2 years, 4-monthly to 5 years and annually thereafter.
Bleomycin toxicity was also a possible contributory factor in three further deaths (one BEP, two CBOP/BEP) from infective respiratory conditions (postoperative adult respiratory distress syndrome [ARDS] [one], pneumonia [two]) that occurred 2 3 mo after completion of protocol chemotherapy.
For example, prospectively assessed QOL (even after completion of protocol treatment) was proposed and performed as one of the secondary end points of the phase III trial of combined therapy of Docetaxel plus Cisplatin and Fluorouracil for advanced gastric or gastroesophageal adenocarcinoma [ 10].
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Reasons to stop treatment in the protocol: normal completion of the protocol after one or two courses IAGO, ineligibility, non-compliance of the patient, excessive toxicity, death, and loss to follow-up (LFU).
It is easy to see that both parties MN and IS are in possession of the same session key upon the completion of the protocol execution, and therefore the protocol satisfies condition 1 of SK-security in Definition 1.
Furthermore, 44 patients were excluded after completion because of protocol violation or missing/irretrievable/unusable blood samples.
The completion rate of protocol treatment was 77% in the S-1 group and 73% in the UFT/LV group.
Completion rate of protocol treatment was 76.5% in the S-1 group and 73.4% in the UFT/LV group (Table 2).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com