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Which term describes a set of subjects that adheres closely to the intention-to-treat principle?

Exclusion set

Statistical sample

Full Analysis Set

The term that describes a set of subjects adhering closely to the intention-to-treat principle is the Full Analysis Set. This approach involves including all participants who were initially allocated to treatment groups, regardless of whether they completed the treatment, adhered to the protocol, or ever received the treatment. The intention-to-treat principle is crucial in clinical trials as it helps preserve the benefits of randomization and reduces bias, ensuring that comparisons between treatment groups are as valid as possible.

In contrast, other terms such as the exclusion set may refer to subjects who are removed from analysis for specific reasons, undermining the intention-to-treat principle. A statistical sample is a broader term that does not specifically connect to adherence to this principle in clinical trials. The controlled group refers to a group receiving a placebo or standard treatment for comparison, which does not encompass the notion of intention-to-treat. The Full Analysis Set is essential in clinical research to foster reliable and unbiased results.

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Controlled Group

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