Statistical Analysis Plan Sample Clauses

Statistical Analysis Plan. Analysis of Agreement Endpoints Analysis of the agreement study endpoints will include measurements from ▇▇▇▇▇ ▇▇▇▇▇▇▇ and the predicate device. Descriptive statistics of each agreement study endpoint will be provided by subject population for each device. .

Statistical Analysis Plan. The outcomes of interest for this aim include maternal outcome (such as hemoglobin HbA1C levels, occurrence of C-section) and fetal outcome (such as occurrence of rate of macrosomia, shoulder dystocia). For a continuous outcome, we will follow the same plan proposed for analyzing the secondary outcome in Aim 2. For a categorical outcome that has more than two levels (i.e. non-binary), we will use Chi-square (or ▇▇▇▇▇▇’▇ exact) tests and ▇▇▇▇▇▇▇-▇▇▇▇▇▇-Haenszel tests which adjust for BMI categories for group comparisons. Poisson regression or negative binomial regression will be conducted to model the effects of intervention and potential predictors on the categorical endpoint. Model selection and checking will follow the standard procedure for these models. Power. Aim 3 will explore the impact of the lifestyle intervention in preventing maternal and fetal complications between women in the lifestyle intervention group and women receiving standard care. We anticipate that Aim 3 will be underpowered to assess many of the mentioned clinical outcomes, but the results of this exploratory aim will serve as the basis for sample size calculations to support a larger, future trial designed to investigate the effects of the intervention in prevention of maternal/fetal complications and costs associated with such complications.

Statistical Analysis Plan. The Parties shall cooperate in good faith in preparing any statistical analysis plans (including, but not limited to, determining the primary statistical endpoints) with respect to the Product, including, but not limited to, with respect to any studies set forth in the Initial Joint Development Plan and Budget; provided that in the event of any disputes with respect thereto, Lundbeck shall have the final determination with respect to any such statistical analysis plan with respect to the Product in the Territory and Myriad shall have the final determination with respect to any such statistical analysis plan with respect to the Product outside the Territory.

Statistical Analysis Plan. The statistical analysis plan for Aim 2 is similar to that for Aim 1. Specifically, we will code the primary outcome for Aim 2, the occurrence of carbohydrate intolerance and GDM at 24-28 weeks of gestation as 1 in presence of carbohydrate intolerance and GDM and 0 otherwise. Model selection and checking will be the same as that proposed for Aim 1. For the secondary outcome, fasting blood glucose and HbA1C values, we plan to compare them between the standard care group and the intervention group using two-sample Wilcoxon test. Linear model will be fitted to account for effects of other relevant covariates on this outcome. Normality assumption will be checked. In case this assumption is violated, standard transformation techniques will be applied. Model selection will use classic stepwise, backward, or forward strategy.

Statistical Analysis Plan. A final statistical analysis plan will be developed and approved by both Opthea and the study biostatistician prior to database lock. The primary efficacy analysis will occur when target enrollment or randomization is complete and each participant either completes the week 12 follow-up visit or withdraws from the study. The final analysis for all other endpoints will occur after all participants complete the week 24 follow-up visit. The following is a summary of the planned analyses; full details are captured in the statistical analysis plan. Continuous variables will be summarized using descriptive statistics (N, mean, standard deviation, median, minimum and maximum), while categorical variables will be summarized as counts and percentages of participants in each category. Results will be presented by study arm as appropriate. The primary efficacy analysis will be presented using the PP analysis set. Secondary efficacy analyses will be presented using the PP and ITT populations. For efficacy analyses, no missing values will be imputed as the primary efficacy analysis is on the PP population. Safety analyses will be presented using the safety and ITT populations. All baseline and demographic summaries will be based on the ITT dataset.

Statistical Analysis Plan. Olema shall provide Novartis with a draft statistical analysis plan (“SAP”) for the Study. Novartis shall have the right, but not the obligation to provide comments to the SAP, such comments (if any) to be provided within [***] after Novartis’ receipt of the draft SAP. Olema shall have the final decision regarding the contents of the SAP; however, ▇▇▇▇▇ shall reasonably consider any comments provided by Novartis regarding the SAP before finalizing. If any material changes are proposed to the Protocol (as defined in Section 4.1 above), Olema shall provide a copy of any proposed amendments to the SAP to Novartis for review and comment, and Olema shall reasonably consider any comments provided by Novartis regarding the proposed amendments to the SAP.