C80263Level 2

Rationale

**Semantic type:** Classification

**Definition:** An explanation of the fundamental reasons.

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C142705Study Design Rationale

C171182Protocol Treatment Arm Assignment Rationale

C181233Brief Rationale for Protocol Change

C181234Overall Rationale for Protocol Amendment

C185636Treatment Modification Rationale

C203927Study Rationale

C215608Study Change Rationale

C218730Rationale for Trial Estimand

C218731Rationale for Trial Control Type

C218732Rationale for Trial Duration

C218734Rationale for Interim Analysis

C218752Rationale for Investigational Trial Intervention Dose and Regimen

C218767Study Subject Discontinuation Rationale

C219696Trial Justification

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