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Sixty nine uLMA placements were completed and an analysis was performed (based on "per protocol" and not intention to treat).
Similarly, an analysis based on per protocol treatment allocation also showed no evidence for treatment group differences in both an unadjusted and adjusted analysis (Oxford hip score, P=0.574; Harris hip score, P=0.179).
All available cases with enough tissue for sampling were identified in the Department of Pathology at Stanford University Hospital (SUH) from 2000 to 2007 with the diagnosis of either DCIS and no development of IBC over a median follow-up of 9 years or DCIS with concurrent IBC present, based on per protocol assessment by SUH pathologists.
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The two groups were not significantly different in change of pain score at 4 weeks (P = 0.285) or at 12 weeks (P = 0.151) based on per-protocol analysis.
Univariate comparisons of the primary and secondary outcomes between the two groups based on per-protocol and ITT analyses are presented in Table 2.
CI, confidence interval; N, number of subjects in group; Responses are based on per-protocol immunogenicity cohort before vaccination and at vaccination + 21 days; responses at time-points post-vaccination are based on per-protocol immunogenicity persistence cohorts; Primary vaccine strain, H5N1/A/Vietnam/1194/2004; booster strain, H5N1/A/Indonesia/5/2005.
Based on per-protocol analysis of the participants who finished the study, at completion, A1C in the insulin-treated group was 6.1 ± 0.6 versus 6.0 ± 0.8% in the triple oral group (P = 0.26).
Due to the study design (non-inferiority), the main conclusions of the statistical analyses of the primary efficacy endpoint were based on the per protocol set (PPS), which included all members of the full analysis set (FAS) with no major protocol deviations.
Sample size calculation and confirmatory analysis are based on the per protocol population [ 22].
All statistical analyses were conducted based on the per protocol set (PP).
Analysis of the primary efficacy endpoint, was based on the per protocol analysis set (PPS) and the safety analysis was based on the full analysis set (FAS).
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