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Table 1.

Study Designa.

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Table 2.

Analysis Descriptions.

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Table 3.

Patient Characteristicsa.

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Table 4.

Patient Comparisons with the 2006 CF Foundation Patient Registrya.

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Figure 1.

Key Univariate Relationships.

HMGB-1 had strong statistically significant associations with A) concurrent FEV1% and B) number of APE suffered in the year prior sputum sample collection. These results illustrate the immediate clinical relevance of HMGB-1. C) GM-CSF measured at APE time-points had an extremely strong univariate association with the size of the APE-associated decline in FEV1% for each of 26 patients in Group 2. D) Although the univariate relationship with APE-associated FEV1% decline was weak (Table S3), the addition of IL-5 as a covariate to GM-CSF significantly strengthened the multivariate linear regression model of APE-associated decline in FEV1% (Table 5).

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Table 5.

Multivariate models for concurrent outcomes and APE-associated predictions.

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Table 6.

Proportional Hazards Models of Time-to-Eventa.

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Figure 2.

Kaplan-Meier Curves for the Time from Stable Sputum Collection to First Event.

The curves illustrate the difference in time to A) first APE and B) death or censoring by listing for lung transplantation for patients with HMGB-1 measurements higher and lower than the value of 6.0 (log ng/ml). The value is the rounded median of the actual HMGB-1 data for both the 26 patients in A and the 76 patients in B. P-values shown are the results of log rank testing [52]. These graphs show the results of evaluation of HMGB-1 simplified to high or low values, which are consistent with the proportional hazards modeling [29] of the effects of HMGB-1 as a continuous variable. Models were tested for consistency with proportionality [31] (Table 6).

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Table 7.

Testing Validation Results for Mutual Consistency.

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