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The intervention will be delivered utilising the FRAMES approach [ 25], and will be protocol driven with regular clinical supervision and observation to maximise intervention integrity.
A supplementary analysis will be per protocol for the TIPIT study.
These experiments will be replicated in Protocols 5 and 6.
Protocols should describe any retention strategies and define which outcome data will be recorded from protocol non-adherers.
The influence of deviations on the treatment protocol will be evaluated using a per protocol analysis.
The investigators will attend a 3-hour training workshop on the protocol and will be provided with a protocol and relevant SOPs.
If we treat it like that there will be no Paris protocol," he said.
The F.D.A. will be reviewing the protocol for Stage 2 of the trial; results are expected in 2002.
If this works, they will be the goto protocol for data providers and consumers.
These experiments will be replicated in Protocol 1.
This experiment will be replicated in Protocol 5.
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