A Large Multicenter Double-Blinded Randomized Placebo-Controlled Study Is Being Planned

question 863

Multiple Choice

A large multicenter double-blinded randomized placebo-controlled study is being planned to evaluate a new medication.  Primary endpoints addressing mortality benefits are chosen, and a comprehensive analysis strategy is specified, including for predefined subgroups.
In discussing the advantages of this study design, which of the following represents a benefit of randomization?

• A)Randomization can be performed at the level of subgroup analysis
• B)Randomization distributes known and unknown variables equally among the study groups
• C)Randomization ensures that the study results are statistically significant
• D)Randomization ensures that the study sample is representative of the population
• E)Randomization prevents group allocation concealment from study participants and investigators

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Definitions:

Nonsynonymous Mutation

A type of nucleotide substitution in a gene sequence that leads to the coding of a different amino acid, potentially altering the function of the protein.

Synonymous Mutation

A genetic mutation that does not alter the amino acid sequence of a protein due to the redundancy of the genetic code, often considered silent mutations.

Amino Acid

The building blocks of proteins, consisting of a basic amino group, an acidic carboxyl group, and a unique side chain.

Codon

A sequence of three nucleotides which together form a unit of genetic code in a DNA or RNA molecule.