When analyzed separately, however, a significant advantage over placebo was seen with combination therapy in both studies, while olanzapine as monotherapy was more effective than placebo in only 1 of the 2 studies (Data on File, Eli Lilly and Company).
This was consistent with the previous in vitro drug drug interaction studies (data on file, Eli Lilly and Company).
The efficacy measures used in this study (clinician and patient ratings) were found to be appropriate for the assessment of SMF following formal validation studies (data on file).
The individual patients' data (IPD) of four prospective, randomized, single-blind, multicenter, comparative studies (data on file, Rosen Pharma GmbH), so far unpublished, were available for this IPD meta-analysis.
In these and other observational studies (data on file), psychometric properties were found to be appropriate for assessment of the outcomes.
An unexpected pharmacokinetic profile was observed in all five patients, which was substantially different from the animal pharmacokinetic studies (data on file, Eli Lilly and Company, Figures 3 and 4).
12 At 1 day after completion of sequential therapy on the face, the mean composite LSR score in the present study was 10.1 (range 8.9 11.3; n=57) compared with 9.3 (range 8.7 9.8; n=217) in the ingenol mebutate monotherapy study (data on file, LEO Pharma A/S, 2013).
0.85 +/- 0.09 study data on file hrQoL baseline (ACLR) 0.80 beta dist.
Furthermore, no cardiac toxicity was detected in a cardiovascular safety study (data on file, FPD 1055).
The sample size calculation was based on a residual standard deviation of 10.95 ms for the primary endpoint observed in a previous indacaterol study (data on file).
