Sas 9.40 statistical software

The study enrolled 40 healthy volunteers into two cohorts. In Cohort 1, 16 participants were enrolled and randomized in a 3:1 ratio to astodrimer sodium nasal spray (N = 12) or placebo nasal spray (N = 4). In Cohort 2, 24 participants were enrolled and also randomized in a 3:1 ratio to astodrimer sodium nasal spray (N = 18) or placebo (N = 6). A computer generated (SAS 9.40 statistical software, SAS Institute, Inc., Cary, NC, USA) randomization list specifying a block size of 8 was used. A total of 5 blocks resulting in 40 randomization codes were generated. The randomization list was only accessible to the unblinded statistician and the pharmacist. Participants deemed eligible by the principal investigator were sequentially assigned randomization codes and dispensed astodrimer sodium nasal spray or placebo according to the randomization list by the pharmacist, who had no other involvement in the study.
The astodrimer sodium nasal spray and placebo nasal spray were packaged in identical containers with identical labelling. The placebo consisted of the same aqueous formulation as astodrimer sodium nasal spray, but without astodrimer sodium, and was identical in appearance and all other ways. The participants, investigator, and other site staff administering product or assessing outcomes were all masked to group assignment.

The sample size was not selected for inferential statistics but to allow sufficient qualitative evaluation of the safety of multiple nasal applications of astodrimer sodium nasal spray. It was assumed that the probability of observing at least one TEAE or SAE in a participant applying the product (i.e., event presence or absence) follows a binomial distribution. A sample size of 30 participants receiving astodrimer sodium nasal spray provided a high probability (> 95%) of observing at least one TEAE or SAE if the true event rate was greater than or equal to 1 in 10 users.
The primary safety analyses included all participants who were randomized and received any amount of astodrimer sodium nasal spray or placebo. The secondary assessment of absorption included all participants in Cohort 1 who were randomized and received any astodrimer sodium nasal spray.
Categorical endpoints were summarized by treatment group as frequencies, percentages of the total number of participants, and total number of events. TEAEs were coded using MedDRA v23.1. SAS 9.40 statistical software (SAS Institute, Inc., Cary, NC, USA) was used for all analyses.