2.8.2. Target population for analysis.
DISEASE
The population to be analyzed is defined as follows.Full analysis set (FAS): The FAS will comprise all study subjects who underwent randomization, excluding the following study subjects: cases that do not meet the eligibility criteria (e.g., diagnosed with another disease, violating objectively determinable inclusion or exclusion criteria), cases that have never received any study treatment after randomization, and cases with no measurements made after randomization.Per protocol set (PPS): The PPS consisted of the FAS population, excluding the following study subjects: cases with unavailable measurements of the primary endpoint and cases with serious protocol violations (e.g., misassignment, failure to meet eligibility, use of prohibited medications, and noncompliance with medications).