Analysis Methods Sample Clauses

Analysis Methods. A mixed effects repeated measures model will be utilized to test these hypotheses. The model will include terms for lens, period, and sequence. Within-subject correlation due to eye and the crossover design will also be accounted for in the model. Lens difference (PRECISION1 minus Biotrue) and the corresponding one-sided 95% upper confidence limit will be computed. Noninferiority in distance VA will be declared if upper confidence limit is less than 0.05.

Analysis Methods. A binary variable will be defined for each subject to indicate whether the CLCDVA at Week 1 Follow-up is no worse than 20/20 in both OD and OS, and the corresponding proportion will be computed for each lens using the number of subjects as the denominator. . From the two-sided 95% CI on the lens difference ( minus Biofinity), noninferiority in proportion of subjects achieving 20/20 or better in CLCDVA in both eyes will be declared if the lower confidence limit is greater than -0.10. .

Analysis Methods. The primary analysis of this study was to examine marijuana as a potential risk factor for phthalate exposure while also considering other sources of exposure, potential confounders.. Phthalate concentration values that were below the limit of detection were imputed by dividing the functional sensitivity for each respective phthalate metabolite by the square root of 2. Proc Standard was used to normalize the distribution of the data. Simple linear regression methods were used to analyze each continuous and two level categorical covariate and phthalate concentrations. A 95 % confidence interval and beta coefficient were generated with each simple linear regression. Correlation tests were used to analyze the correlation between each continuous variable. A multivariate linear regression model was then generated with each dependent variable (phthalate metabolite) and all independent variables assessed in the bivariate analyses. Continuous covariates that were used include maternal age, and maternal body mass index (BMI) as determined by measured height and weight at the first prenatal visit between 8-14 weeks’ gestation. Categorical covariates that were used include income level, condom usage, alcohol usage, tobacco usage, maternal educational attainment, all oral over the counter and prescription medication, and vitamin usage. The overall F test was used to analyze the overall outcome. The significance of the t test was used to measure the marginal significance of the predictor within the model. All statistical procedures were conducted using SAS 9.4. An alpha level of 0.05 was considered statistically significant. Descriptive statistics of the cohort examined are provided in Table 2. The overall mean age of the women in the study was 25 years old. The overall mean BMI at the first prenatal visit was 29.10 kg/m2. This is a socioeconomically diverse cohort, with 38% of women in the study reporting an income below 100% of the federal poverty line. Only 10 % of the pregnant women reported condom use during the month proceeding the survey. Additionally, 12 % of study participants reported tobacco usage and alcohol usage was present among 6 % of study participants. Most the study participants had not attended education higher than high school (62 %). Approximately 42% of study participants reported use of oral over the counter/ prescription medications, and 21% % of study participants reported usage of non-oral over the counter/ prescription pharmaceuticals. Addit...

Analysis Methods. For continuous variables, descriptive statistics (mean, standard deviation, N, median, min and max) will be provided for actual value and change from baseline at each visit. For categorical variables, N and percent will be provided for each category at each visit. Any additional p-values from t-statistics or chi-square type statistics will be provided accordingly only for descriptive purpose.

Analysis Methods. For the superiority hypothesis tests, treatment group comparison for UCIVA will be made and the first secondary objective will be demonstrated if p<0.025 from a repeated measures analysis of variance at a Type I error rate of 2.5%. Tests at each visit will be reported with Visit 4A (120-180 days) prospectively identified as the primary time point of interest. The two-sided 95% confidence intervals will be reported for the difference between treatment groups at each visit. For the fourth and fifth secondary objectives, superiority will be demonstrated if p<0.05 (or p<0.025, depending on the gatekeeping) for UCNVA and UCDVA at Visit 4A (120-180 days), respectively. 1. If the upper bound is less than the margin, the null hypothesis will be rejected and the TNFT00 IOL will be concluded non-inferior to the 839MP IOL for UCDVA. The two-sided 95% confidence intervals will be reported for the difference between the treatment groups at each visit. 1. If the upper bound is less than the margin, the null hypothesis will be rejected and the TNFT00 IOL will be concluded non-inferior to the 839MP IOL for UCNVA. The two-sided 95% (or 90%) confidence intervals will be reported for the difference between the treatment groups at each visit. Summaries of logMAR visual acuity will also include two-sided 90% confidence intervals. A composite visual acuity endpoint comprising binocular uncorrected visual acuity at Distance (4 m) and Near (40 cm) will be summarized as a categorical variable with the following categories: 20/20 or better (≤0.04 logMAR), 20/32 or better (≤0.14 logMAR) and 20/40 or better (≤0.24 logMAR). Defocus curves will be generated for binocular defocus data, including two-sided 90% confidence intervals, with the amount of defocus along the x-axis and logMAR VA at each defocus point along the y-axis. To examine inter-site variation in outcome, forest plots of near, intermediate and distance visual acuity will be produced by plotting the difference in means and associated standard error for each site. Contrast Sensitivity will be scored and analyzed per contrast sensitivity unit instructions. Responses to the satisfaction question will be analyzed as a categorical variable.

Analysis Methods. Summary statistics will be provided. • Listing for VA changes from Dispense of 2 or more lines during the study

Analysis Methods. All eligible eyes will be used for the analysis. For unilaterally implanted subjects, only the eligible eye, for bilaterally implanted subjects, both eyes will be used for the analysis. The superiority of T2 to T0 regarding refractive cylinder is to be demonstrated when there is a statistically significant difference between the outcome in this study and the historical threshold of 29.2%.

Analysis Methods. Analysis methods for sizing shall be consistent with Section 4-8 and standard engineering practice. Imported water shall not be included in the existing runoff from the site. The applicant shall submit clearly labeled calculations including:  Hydrologic parameters and source(s) of data  Analysis methods used  Additional assumptions made (infiltration rates may require field tests, consult Public Works before proceeding)  Spreadsheet, printouts, or hand calculations  Results (required volume, orifice sizes, stage discharge curve for hydrograph methods, etc.)

Analysis Methods. For each of the supportive effectiveness endpoints, descriptive summary statistics will be computed according to the scale of measurement.

Analysis Methods. A mixed effects repeated measures model will be utilized to test these hypotheses. The model will include terms for lens, visit (Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up), and lens-by-visit interaction as fixed effects, Within-subject correlation due to eye will also be accounted for in the model. Lens difference ( minus Biofinity) and the corresponding two-sided 95% CI will be computed for 1-Week Follow-up. Noninferiority in CLCDVA will be declared if the upper confidence limit is less than 0.10.