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Analysis of a Phase 2 RCT

This study evaluates the efficacy of a new antihypertensive drug (Trx) using data from a Phase II randomized controlled trial across three clinical sites. Despite "contamination" from protocol deviations at Site 3, a measurement device switch at Site 2, and differential dropout, linear regression analysis reveals a significant reduction in systolic blood pressure (p < 0.001). Inferential testing confirmed that measurement shifts and missingness—identified as Missing At Random (MAR)—did not invalidate the primary findings. Sensitivity analyses excluding Site 3 demonstrated stable treatment effects, confirming the drug’s robust clinical performance despite real-world data irregularities.

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This is a Phase II RCT across three sites which showed Trx significantly reduced systolic BP (p < 0.001) via linear regression, despite Site 3 deviations, Site 2 device switch, and MAR dropout. Inferential tests and sensitivity analyses (excluding Site 3) confirmed robust efficacy.

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