Longitudinal analysis on time to elevation mood episode and time to recovery from mood elevation episode did not show any significant difference in relation to BD subtype, highlighting the importance to futher characterize and differentiate BD II from BD I not only in light of the manic/hypomanic symptom dimension but, particularly, in terms of long-term depressive burden.
For the 16 patients who had grade 3/4 ALT elevations on-treatment, the median time to elevation was ∼10 weeks (range 4 to 23 weeks), with rapid reversal in ∼2.5 weeks after discontinuation.
Capturing and comparing time to elevation of liver test results across treatment groups is of key importance not only for understanding and adequately interpreting a potential liver safety signal but also for managing the risk associated with any effects of the study drug on the liver, e.g. in terms of defining adequate monitoring intervals.
An exponential function was chosen to model the time to ALT elevation, so that the cumulative probability of this elevation at month 6 was <1, taking into account the possible fluctuation of ALT and the possible absence of detection of ALT elevation in some subjects.
122/127 co-infected subjects were included in the time to ALT and time to Fib-4 elevation analysis according to TNF-a levels and sCD14 levels.
One hundred and thirteen HIV/HCV co-infected individuals were included in this time to ALT and time to Fib-4 elevation sensitivity analysis.
We used the standard approach of censoring patients with prior opposite pole episodes in assessing time to depressive/mood elevation recurrence (Tohen et al. 1990).
However, the association between current irritability and time to mood elevation recovery (Log-Rank p = 0.35, HR = 0.57; 95 % CI 0.17 1.9; p = 0.36, in 42 vs. 11 manic/hypomanic/mixed patients with vs. without current irritability, not illustrated) was non-significant.
Retention of the bronchoscope in the airway was limited to no more than five minutes at a time, to limit ICP elevation.
Additionally, our sample size, though substantial, had insufficient statistical power to be able to adequately assess relationships between current irritability and times to mood elevation recurrence/recovery.
In contrast, associations between BD II versus BD I and times to mood elevation recurrence (log-rank, p = 0.13, HR = 0.44, 95% CI 0.14 1.3, p = 0.14, in 41 versus 64 recovered patients, not illustrated) and any mood episode recurrence (log-rank, p = 0.30, HR = 1.3, 95% CI 0.78 2.3, p = 0.30, in 41 versus 64 recovered patients, not illustrated) were non-significant.
