Sas statistical package for windows

Efficacy was analysed for the ITT population with a sensitivity analysis for the per‐protocol (PP) population. Patients with lack of compliance, intake of forbidden concomitant medication, violation of eligibility criteria or early discontinuation due to reasons not related with the study drug were excluded from the PP population. Safety analyses were performed for the safety population, which included all patients who took the study drug at least once. As enrolment of patients was terminated prior to the planned interim analysis due to an insufficient patient recruitment rate, a two‐stage group‐sequential adaptive design was no longer appropriate and the test‐statistical procedure was adjusted (Fisher's exact test). To test the hypothesis of the primary endpoint, the type I error rate was defined as α = 0.025 (one‐sided). All other statistical tests were performed two‐sided with a significance level of α = 0.05 on an exploratory basis. All statistical analyses were conducted using the SAS statistical package for Windows (SAS Institute, Cary, NC, USA), version 9.4.

The difference between DR and non DR was assessed according to variables related with retinopathy. The correlation of DR with different risk factors was also evaluated. Logistic regression analysis was applied to assess predictors of the DR presence/absence.
Description of the qualitative variables was performed using absolute (i.e. counts) and relative (i.e. percentages) frequencies while quantitative variables using mean (standard deviation [SD] or 95% confidence interval [95%CI]) or median (interquartile range [IQR]) values. The results of the multivariable analysis included the odds ratios (ORs) and 95%CI. The software used in the analysis was SAS version 9.2 for Windows.Categorical and continuous variables were summarised as percentages and mean ± standard deviation (SD), respectively. Missing values were not included in the count. Qualitative variables were analysed by the Chi-square test or the Fisher exact test, as appropriate, and quantitative variables were analysed using the t-test or the Mann-Whitney test. A p-value < 0.05 was considered statistically significant. Statistical analyses were performed using the SAS® statistical package for Windows (version 9.2, SAS Institute Inc., Cary, NC, USA).