- Data analysis: After the test plan has been determined, the statisticians will be responsible for consultation with the major researchers and formulate a statistical analysis plan. All data will be analyzed using SAS9.3 software. Statistical analysis includes actual number of participants in the two groups, the conditions of dropped-out and eliminated cases, demographic and other baseline characteristics, efficacy analysis, and safety analysis. Besides the statistical methods listed below, detailed and additional exploratory analyses may be necessary, and may be identified in the study report and analysis plan.