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As one function of a pilot study is to determine what to do when unforeseeable situations occur, we anticipated that protocol amendments would be required.
It is anticipated that the protocols described herein will assist in the fast, high throughput monitoring of autophagy that can support other existing autophagy assays.
It is anticipated that treatment protocols that result in higher response rates will also result in higher survival rates in following phase III studies.
The protocol anticipated maximum antibody responses on Day 70, 14 days after third vaccination; however, the increase in antibody responses from Day 42 to Day 70 was significant only for the 80 µg AMA1 group, as shown by the estimates of fold change with 95% confidence intervals and p-values.
The protocol anticipated comparisons between 5 cohorts.
The initial vaccination protocol anticipated natural M. bovis challenge from close contact with infected herd members.
The basis of the DMC recommendation was futility (i.e. no prospect of demonstrating the treatment benefit anticipated in the protocol) as well as safety concerns.
It is possible that prestudy ICS adherence was lower than anticipated by the protocol, as suggested by the high degree of FEV1 reversibility seen at screening.
As we anticipated at the protocol stage, none of the included trials were conducted in the context of EVD or a similar medical emergency.
The original protocol anticipated using diamorphine, but between the trial approval and start of the trial, the practice changed to using morphine and the protocol was amended to reflect this.
In addition, it is anticipated that the protocol will be rolled out initially at one to two sites with the remaining sites coming online three to eight months later.
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