The estimated power for STH and DMFS data in the FITHOS is based on a 4-year study period, and therefore this interim analysis after 1 year provides insufficient power for caries data.
After the interim assessment, this regimen was altered to taper GL over 4 days (75%, 50 %, 25, and 0% GL dose on dand 1, 2, 3, and 4, respectively).
The adaptive design also allows stopping of the trial midway if none of the doses show a statistically significant effect after the interim analysis; this will reduce the duration of the trial and result in cost saving.
In the case of Lloyds this could begin after the interim results on 1 August.
Auditors questioned the terms of the deals after the interim results were published.
Last week, the shares fell after the interim results were delayed until Monday.
Fleury and Don Maloney, the acting general manager, met last Friday, after the interim coach, John Tortorella, had expressed displeasure with Fleury.
In addition, it is discussed which null hypotheses are tested and may be rejected if the study design is changed after the interim analysis.
After the interim analysis, these increments were changed to 2 and 4 volumetric "units," respectively.
A comprehensive, updated sample size justification and statistical plan will be created together with an interim report after the interim analysis.
