After reinvestigation of clinical data and MRI, three patients were excluded: one who was first diagnosed as DLB, another had infarction in the brain stem on the T2-weighted image, and the other had complication of brain amyloid angiopathy.
The age of the 208 included patients did not differ from that of the 380 excluded ones who stayed for longer than 48 hours (mean [± standard deviation] age: 57 ± 16 years versus 54 ± 19 years), but their length of stay was longer (mean 21±1919 days versus 13 ± 18 days; P < 0.000001) and their severity of illness or injury was greater (SAPS II score: 44 ± 17 versus 37 ± 18; P < 0.0001).
Of all patients who received the study drug, 286 were analysed for efficacy, excluding one subject who was not evaluated for efficacy properly after receiving the final dose.
Fifty-four participants had died at follow-up (excluding one participant who died, but date of death was not known), giving a 2-year survival rate from the time of discharge of 87%9595% CI, 83 90%) and an annual mortality rate from the time of discharge of 0.07 deaths per person-year (95% CI, 0.05 0.09; Figure 3).
We examined the viral load in 39 of 40 anti-HCV-positive patients, excluding one patient who cleared serum HCV RNA naturally (group 1-A).
This analysis incorporates data available from 46 patients, excluding one patient who was entered but was subsequently deemed ineligible (median follow-up 38.6 months).
After excluding one patient who did not receive the study drug, 101 Japanese patients (trastuzumab plus chemotherapy, n = 51; chemotherapy alone, n = 50) were included in this subgroup analysis.
Of the 28 subjects treated in the study, 27 subjects, excluding one subject who discontinued from the study in period II, were included in the analysis of drug interaction.
We also conducted analyses excluding one participant who had very low MDI and PDI scores at 24 months (scores of 50 for both), and results were similar, with the exception of a weaker effect estimate for 24-month PDI [adjusted β, manganese quintile 5 × continuous lead: excluding participant, –1.01 (95% CI: –2.32, 0.30); total sample, –1.60 (95% CI: –2.93, –0.27)].
Of the 608 women who received DXA scans, we excluded one participant who was missing data on weight, and six participants missing data on current use of postmenopausal hormone therapy (estrogen or estrogen plus progestin).
