Sas versions 9 3 and 9

The present analyses focused on data from the part I placebo-controlled 78-week treatment phase. All treated participants were used in safety analyses. Adverse events within 14 days postdose were collected verbatim and mapped to Medical Dictionary for Regulatory Activities (MedDRA) version 20.0 lower-level terms which were then mapped to preferred terms and system organ classes. In addition, selected adverse event terms were clustered in an unblinded and post hoc manner to form “composite” adverse event groupings of related adverse events. The composite adverse events included rash/dermatitis/urticaria, delirium-like events, psychotic symptoms (hallucinations and delusions), injuries and falls, overactive bladder events, sleep disturbance events, and syncopal-like events. Exposure-response relationships were calculated for select preferred or composite adverse event terms. The numbers of participants exceeding predefined limits of change for laboratory, ECG, and vital sign measures were calculated. Additional analyses were performed as detailed in the relevant sections.
All statistical analyses were performed using SAS Versions 9.3 and 9.4 (SAS Institute, Cary, NC, USA).

Generalized linear models were used to evaluate the relationship between covariates and the outcomes of interest (neonatal mortality and pSBI) and to develop point and interval estimates of relative risk (RR) associated with those risk factors. Generalized estimating equations accounted for the correlation of outcomes within cluster to develop appropriate confidence intervals. Analyses were adjusted for randomization strata. Models were log binomial when possible, otherwise Poisson models were utilized. Pre-trial data were analyzed to assess the status of various measures prior to trial implementation. All analyses were done by RTI International with SAS versions 9.3 and 9.4 (SAS Institute, Cary, NC, USA).