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Can continuous designs without a priori-specified analysis time points (e.g. triangular test [1]) be adapted to an agreement setting?
The model allows predicting outcomes (death, HF hospitalization, NYHA class distribution) up to 5 years with distinctive analysis time points at 1, 2, 3 and 4 years.
For subsequent analysis time points, annual increases in the percentage of these two main events as observed in the CARF-HF study between one and two years were applied [20].
Employing one, two, or three interim analyses before the final analysis, statistical testing at all interim analysis time points was adjusted for multiple testing in each strategy by adjusting significance levels as described above.
Additionally, tissue burdens (as log10 CFU/g) were determined at the analysis time points.
Therefore, for further analysis, time points 6 and 24 hours were combined and compared to corresponding untreated control samples.
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Any patient with missing data at the analysis time point was classified as having radiographic progression.
Each analysis time point consisted of triplicate samples, and the mean for each probe set was used in the analysis.
A last-observation-carried-forward (LOCF) analysis was applied if data were unavailable at the analysis time point.
In the case of any interim analysis the database will be frozen at the analysis time point.
The sponsor was unblinded at the 48-week analysis time point, but the investigators and patients remained blinded until the 96-week analysis.
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