Statistical analysis
TEAEs, pain
Statistical analysis of the safety data included group-specific comparisons of the following variables: (i) total number of TEAEs, (ii) number of TEAEs experienced per subject, (iii) number of TEAEs classified as {mild/moderate/severe}, (iv) relationship of TEAEs to treatment classified as {not related/unlikely/possible/probable/definite} and (v) number of TEAEs classified as {mild and unlikely to be related to the investigated treatment/mild and possibly related to the investigated treatment/moderate and unlikely to be related to the investigated treatment/moderate and possibly related to the investigated treatment}. According to the protocol of the present study these comparisons were performed for the following time periods: from BL to W24 post-treatment (considering only data of the former studyStatistical analysis of the efficacy data included calculation of the group specific mean, standard error of the mean and median as well as group-specific comparisons of the following variables: (i) ASES Total score, (ii) SF-36 Total score, (iii) VAS pain score, (iv) active and passive ROM and (v) tear volume measured on MRIs. According to the protocol of the present study these comparisons were performed at BL and at W24 and W52 post-treatment (data of the former studyIn all analyses, a p value < 0.05 was considered statistically significant. Calculations were performed using GraphPad Prism (Version 9.4.1 for Windows; GraphPad Software, San Diego, CA, USA).