2.2. Efficacy measures (WSRS, GAIS, and satisfaction)

The study primary end point was a noninferiority improvement in the NLF based on comparison of investigator‐reported WSRS score (range 1 [none] to 5 [extreme] at 3 months; Figure S1). In addition, investigator‐reported WSRS scores were collected at months 1, 3, and 4 and monthly from month 6 to 12 or until the subject had completely absorbed the filler. Investigator‐reported Global Aesthetic Improvement Scale (GAIS; range 5 [worse] to 1 [very much improved]; Figure S2) was also collected at each follow‐up time point for 12 months or until the subject had completely absorbed the filler. At each post‐treatment time point until the filler was absorbed, the subject rated their satisfaction with their esthetic results for each side of the face (range 0 [no benefit] to 10 [maximum benefit]).

To evaluate the performance of both fillers, variation in mean WSRS score over the first 3 months was calculated using the Wilcoxon (Mann‐Whitney U test) test. Distribution of WSRS and GAIS scores for each filler over time was assessed using a chi‐square test. Multivariate analysis (ANOVA) was used to assess correlation between improvement observed and baseline WSRS score.