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Ten volunteers completed all of the experiments and none were excluded or withdrawn.
Another two patients were excluded: One withdrew consent, the other was unintentionally not intraoperatively monitored.
Eight were excluded; 6 withdrew consent, 1 was screened twice and 1 was unable to give a detailed history.
Two (2%) were excluded; one withdrew consent and the other had bilirubin and transaminase levels ⩾1.5 upper limit of normal.
Additional file 1: Chart 1 demonstrates the numbers of patients who were excluded, who withdrew, or who missed assessments.
Of those 93 declined and 44 were excluded or withdrew, 298 remained (general surgery n = 205; urology n = 60; orthopedic n = 33).
Out of 36 recruited patients, seven had to be excluded (three withdrew consent, two were too frail for repeated testing, one was shown to have no cortical stroke after enrolment, and one was lost to follow-up).
This effect was not restricted to the first year, but was present in year 2. In the total cohort, 106 of 838 (12.6%) women were excluded or withdrew before year 1 scans because of logistical problems.
The baseline characteristics (age, anthropometry, body composition, and biochemical data) of the volunteers who were excluded or withdrew from the study did not significantly differ from those who completed the study (Table 1).
The primary endpoint was OS in the modified intent-to-treat (mITT) population, i.e. all randomized patients, excluding those withdrawn prematurely from the study for a well-documented non-treatment related cause, with OS measured from the date of randomization to the date of death.
This is classified as withdrawn, excluded, or dropped.
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