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In this paper, the HSE protocol will be considered.
The causal relationship will be rated as follows: Reasonably possibility Unclear No reasonable possibility (Adverse event due to the disease under study, pre-existing Medical conditions, study drug withdrawal effect) All adverse events will be reported in the final study report In case of serious adverse event the study will be stopped and a change of the protocol will be considered.
The time from randomization till achievement of the full enteral feeding will be analysed with the Kaplan-Meier estimator, in which full enteral feeding as defined in the protocol will be considered as the sole 'event', while censoring will occur for withdrawal for any cause.
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Here we focus on AF relay as a good start, while the EEs of other relay protocols will be considered in future studies.
If there are some additional aspects for a particular relay protocol, they will be considered after the general description.
The analyses for safety population, randomized population and per protocol population will be considered as secondary.
A per-protocol population will be considered if there are a considerable number of protocol violations.
It is important that the study protocol specify all endpoints that will be considered, including each domain score targeted to support a specific claim.
For each received packet (identified by the classical 5tuple composed of the source and destination addresses, the source and destination port numbers together with the protocol type), only the destination port will be considered and hashed into a random value.
Treatment breaks should be minimized, any break of more than 5 days will be considered a major protocol violation.
Two types of population will be considered for analysis: per protocol and per intention to treat.
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CEO of Professional Science Editing for Scientists @ prosciediting.com