Study Design Clause Samples

Study Design. This is a randomized, multicenter (n=11), open-label, parallel group, controlled research study to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.

Study Design. The goal of this study was to investigate the association between peer status and friendship quality and the mediating role of empathy and prosocial behavior in this association. Because friendship is a dyadic concept involving two friends our study employed a dyadic design using information from both friends. Accordingly, we used the Actor Partner Interdependence Model (APIM) for the analysis of dyadic data (▇▇▇▇▇ & ▇▇▇▇▇, 2000; ▇▇▇▇▇ & Acitelli, 2001; ▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇, & ▇▇▇▇▇, 2002). The APIM includes two types of effects. The actor effect (path a in Figure 1) is the effect of adolescents’ peer status on their own friendship quality rat- ings. The partner effect (path p) is the effect of adolescents’ peer status on their friends’ friendship quality ratings. For example, popular adolescents might rate the quality of their own friendships highly (actor effect), and their friends also might rate the quality of their friendship highly (partner effect). The APIM simultaneously estimates the coefficients for all paths, with the two paths a and two paths b in Figure 1 set equal due to indistinguishabil- ity of dyad members (mutual friends) in this study. An extension of this model is the Actor–Partner Interdependence Mediation Model (APIMeM) (▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇, & ▇▇▇▇▇, 2011). The APIMeM allows for testing of mediation effects within the actor and partner paths. While the APIM is a technique to examine associations between the characteristics of the two members of a dyad, it does not explain why these associations occur. With two members in a dyad, characteristics of both dyad members can be (partly) responsible for existing actor and partner effects. Using APIMeM, it is possible to differentiate between actor mediators and partner mediators on either actor or partner paths. Figure 2 shows the resulting four different mediation paths: actor–actor (aA1–bA1 and aA2–bA2), partner–partner (aP1–bP2 and aP2–bP1), actor–partner (aA1–bP2 and aA2–bP1), and partner–actor (aP1–bA1 and aP2–bA2) mediation. For example: the link between friend A’s peer status and friend A’s friendship perception may be explained by their own prosocial behavior (actor–actor mediation). This link also may be explained by friend B’s prosocial behavior (partner–partner mediation). The link between an friend A’s peer status and FIGURE 1 The actor-partner interdependence model (▇▇▇▇▇ & Acitelli, 2001) friend B’s friendship perception similarly may be explained by friend A’s prosocial behavior (act...

Study Design. As described in Section 1 of the Aging Study Proposal.

Study Design. The scientific and implementation design of the Study are at the direction of the PI. Participation in the Study does not grant the School the opportunity to modify or change the design of the Study in any way, except as otherwise noted in this document or where the Study design is purposefully left to the School to determine (such as with the Custom Questions). Additional information regarding the Study Methodology and the implementation of the Study is set forth in Exhibit A.

Study Design. The study is a multicentre, two-arm, randomised, double-blind clinical trial, using temozolomide as an active comparator. Following completion of radiotherapy treatment according to the ‘▇▇▇▇▇ regimen’, subjects will be assigned to one of two treatment groups, in a 1:1 ratio. The first group will receive temozolomide, in accordance with the labelled dose and schedule. The second group will receive GDC-0084 at a dose of 45mg, once daily.

Study Design. The study is based on a literature review conducted by UW Precision Forestry Cooperative (PFC) for RSAG in 2015 to identify and compare the suitability of remote sensing techniques for mapping riparian forest structural characteristics and composition (i.e., riparian forest metrics): • ▇▇▇▇▇▇, ▇. ▇. and ▇. ▇▇▇▇▇, 2015. Feasibility of applying remote sensing to a riparian stand conditions assessment, Agreement No. IAA 15-118 (Revised 1/1/2015); Prepared for Washington Department of Natural Resources. The review findings were used in refining the focus on types of remote sensing data and their suitability for assessing riparian metrics and lead to the decision of which metric analysis would be feasible to undertake as a pilot to explore the feasibility and relative benefits of using optical and LiDAR remote sensing in the state of Washington.

Study Design. The Phase 2 study will be a randomized, double-blind, multicenter, placebo-controlled trial covering 1 [*] of observation, followed by randomization of qualified subjects to [*] months of treatment and a 1 [*] safety follow-up period. Patients will be postmenopausal women defined as having [*] months of spontaneous amenorrhea, or [*] months of spontaneous amenorrhea with serum FSH levels of > 40 IU/L, or as women who are [*]-weeks post-surgical oophorectomy. Moderate hot flashes are defined as a sensation of heat with flushing but as not being incapacitating, while severe hot flashes are defined as the same but with the element of incapacitation in that the subject must stop current activity. To ensure adequate evidence of therapeutic effect is available, study participants will be required to have frequent hot flashes defined as [*] hot flashes per [*] or [*] to [*] hot flashes per [*]. During the period of observation, patient will document hot flash frequency and severity to prospectively ensure qualification on that criterion. Efficacy will be assessed as the reduction in frequency and severity of hot flashes compared to placebo. The estimated subject number and dose groups are outlined below: It is estimated that the Phase 2 study will require about [*] evaluable subjects to achieve its stated goals. The Phase 2 study will provide evidence of dose-dependent efficacy for ER-306323 and will also provide adequate statistical power to select the optimal dose for Phase 3. The criteria for dose selection will be based on an integration of the major efficacy and safety variables of the study. In addition, the Phase 2 data will also provide statistical evidence of effect of ER-306323 on markers of bone resorption and accretion while providing preliminary evidence of effect of ER-306323 on bone density. Like the Phase lb study, the Phase 2 study will continue to provide additional pharmacodynaraics effects of ER-306323 such as estrogenic effects on serum gonadotropins and serum lipids. Markers of bone effect will again be collected such as serum osteocalcin, bone procoilagen 1 carboxy-terminal propeptide (PICP), N-propeptide of Type-1 collagen (PIMP) and bone-specific alkaline phosphatase. Additional safety information on cardiac (QT) safety and endometrial safety of ER-306323 will be evaluated in more detail through endometrial biopsy in a subset of patients in each treatment group. Finally, estrogenic effect. of ER-306323 on coagulation factors will also be ...

Study Design. The Phase 3 study will be a randomized, double-blind, multicenter, placebo-controlled trial covering 1 [*] of observation, followed by randomization of qualified subjects to [*] months of treatment and a 1 [*] safety follow-up period. Two doses of ER 206323 will be studied. Patients will be postmenopausal women defined as being 45 years old or greater and having [*] months of spontaneous amenorrhea, or [*] months of spontaneous amenorrhea with serum FSH levels of > [*] IU/L, or as women who are [*]-weeks post-surgical oophorectomy. As for the Phase 2 study, hot flash frequency and severity will be established during a pretreatment period of observation and qualifying patients will be then eligible to enroll in the study. As before, the criterion for entry will be a frequency of [*]hot flashes per day or [*] to [*] hot flashes per [*]. Efficacy will be assessed as the reduction in frequency and severity of hot flashes compared to placebo. The estimated subject number and dose groups are outlined below: * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. It is estimated that the Phase 3 study will require about [*] subjects to provide adequate evidence of clinical safety for ER-306323. Since [*]doses of ER-306323 will be administered in this trial, there will be at least [*] patients available to provide endometrial safety data on this product. While powered beyond this need, the Phase 3 study will provide confirmatory evidence of efficacy for ER-306323. The [*] doses to be employed in the Phase 3 trial will include the [*] as identified in the Phase 2 study as well as [*] provide [*]. Efficacy will be based on difference in efficacy [*]. Endometrial safety will be based on self-reported vaginal bleeding, endometrial ultrasound and endometrial biopsy data. Endometrial biopsy data will be assessed according to objective common criteria by a panel of [*]pathologists in [*] independent medical institutions. The Phase 3 study will provide additional long-term safety information on serum lipids and on coagulation markers such as [*]. Influence of ethnicity on efficacy and safety will be assessed and drug-drug interaction effects will also be evaluated where appropriate. BMD will also be assessed at start and end of treatment and treatment effect will be compared to [*]. Markers of bone metabolism will also be assessed. Finally, overall clinical and laboratory safety will be assessed throughout the study.

Study Design. ‌ This will be a multi-center prospective, randomized, controlled study with EBV treatment statistically evaluated using Intent-to-Treat (ITT) analyses. Random assignment will be conducted using an allocation ratio of 2:1; two study participants will be randomized to the EBV Treatment arm for every one participant randomized to the Control arm. A maximum of 183 patients with severe heterogeneous emphysema, who meet study entry criteria, consisting of screening eligibility criteria, baseline eligibility criteria, and procedure eligibility criteria, will be enrolled. Safety and effectiveness of BLVR using the Pulmonx EBV will be evaluated at 1 year. For study participants who have been treated with EBV, a secondary intervention such as valve removal, replacement, or adjustment, as described in this protocol, may be considered during the study follow-up. Long-term data will be collected annually through 5 years. Per the regulatory plan agreed to with FDA, 1 year of follow-up is required pre-approval and the remaining 4 years of follow-up will be conducted post-approval. The flow of study participants through the study protocol is shown in Appendix 1.