Endpoints. The primary endpoints are occurrence of all adverse events including but not limited to: · all MIs · cardiovascular hospitalization · serious ventricular arrhythmias sustained · VT (symptomatic or sustained VT [duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse] · VF · symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block · symptomatic heart failure (NYHA criteria + physical examination OR hospitalization due to heart failure) · renal failure · stroke · death Secondary Endpoints include the parameters: · change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index, left ventricular mass) · change from baseline in regional (infarct related) and global wall motion score · change from baseline in ejection fraction · cardiac rupture · NT-proBNP
Endpoints. The endpoints of this study were differences in inflammatory markers (serum C-reactive protein (CRP) and fibrinogen levels), endothelial function (as estimated using measure- ment of flow mediated dilation (FMD)) and carotid intima-media thickness (CIMT) as a
Endpoints. The impact of MS and CRP on vascular phenotype in DM2 was assessed using sonographic vascular parameters, IMT, and flow mediated dilatation (FMD), as well as the following en- dothelium-related and hemostatic factors: fibrinogen, s-thrombomodulin (sTM), tissue type plasminogen-activator (tPA), plasminogen-activator inhibitor-1 (PAI-1), sVCAM, sE-selectin, and von Willebrand factor (VWF).
Endpoints. (i) Avaya shall use its commercially reasonable efforts to cause (x) the Avaya Endpoints existing as of the Effective Date to be, as soon as reasonably practicable following the Effective Date, and (y) future Avaya Endpoints to be, at all times prior to such Avaya Endpoints being Sold, in each case, compatible with ACO and the other RingCentral Services, and (ii) RingCentral shall use its commercially reasonable efforts to cause (x) the RingCentral Services existing as of the Effective Date to be, as soon as reasonably practicable following the Effective Date, and (y) future RingCentral Services to be, at all times prior to the RingCentral Services being Sold, in each case, compatible with the Avaya Endpoints. To the extent an Avaya Endpoint and the RingCentral Services are so compatible, RingCentral shall offer such Avaya Endpoint as part of its and its Subsidiaries’ product catalogs at least as prominently and positively in the ordinary course of business, in all material respects, as any other RingCentral Offering that is designed to provide substantially similar functionality (taken as a whole) and is then‑currently Marketed in such product catalogs in the ordinary course of business. Each Party acknowledges that the other Party’s performance of its obligations under this Section 2.3(e) depends on such Party’s compliance with this Section 2.3(e) and timely, accurate and effective delivery of all information to make the Avaya Endpoints compatible with ACO, and the other RingCentral Services compatible with the Avaya Endpoints, including such information, cooperation, and assistance reasonably required by either Party. Each Party further acknowledges and agrees that its failure to satisfy any such responsibilities may prevent or delay the other Party’s performance of its obligations under this Section 2.3(e). The Parties agree to work together in good faith to develop a mutually agreed process pursuant to which Avaya will sell to RingCentral certain Avaya Endpoints on commercially favorable terms.
Endpoints. Except as otherwise expressly stated to the contrary in the applicable Cloud Offer Definition or Avaya’s quotation, Avaya is not responsible for the provision of any end points or similar devices necessary to deploy Cloud Services for any Reseller or Cloud End User, including personal end points, personal computers, mobile devices and telepresence or room systems.
Endpoints. Except as otherwise expressly stated to the contrary in the applicable Cloud Offer Definition or any quotation, Distributor is not responsible for the provision of any end points or similar devices necessary to deploy Cloud Services for any Cloud End User, including personal end points, personal computers, mobile devices and telepresence or room systems.
Endpoints. The incidence and course (timing, location of pain and duration) of myalgia after conditioning were the primary endpoints. Secondary endpoint was pain severity according to the WHO pain relief ladder. Other variables noted above were collected to evaluate potential predisposing factors. Descriptive statistics, such as median and frequency, were used to summarize baseline characteristics and outcomes. Odds ratios (OR) were estimated by means of logistic regression to examine the association between conditioning regimen (TREO-based vs. BU-based) and myalgia and adjusted for possible confounding (hemoglobinopathies versus other indications). In the TREO cohort, univariable and multivariable logistic regression was performed to assess whether baseline- or transplant characteristics (age, underlying disease, conditioning regimen, treosulfan exposure) were prognostic for the development of myalgia. All P-values were 2-tailed and considered significant when P<0.05. Statistical 5 analyses were performed using R version 3.6.1 and RStudio version 1.2.5019.
Endpoints. Chapter 2 Pre-clinical performance in the four residence areas was measured by the following time intervals (minutes): Onset of Symptoms to Alert of Emergency Services (patient delay), Onset of Symptoms to Arrival at Catheterization Room (Cath-Lab), Door to Cath-Lab (hospital delay) and Interval between the Alert of Emergency Services to Arrival at the Hospital. Additional endpoints of interest were peak Troponin T and peak Creatine Phosphokinase (CPK) levels. Furthermore, risk profile for CHD was compared between the 4 areas of residency within Xxxxxxxx-Xxxxxx, including risk factors like smoking, hypertension, hyperlipidemia, positive family history, diabetes mellitus and prior myocardial infarction. Lastly, drug treat- ment before occurrence of AMI was studied. Pre-admission medication use of interest was beta-blockers, statins, aspirin, ACE-inhibitors, angiotensine II (AT2)-antagonists, diuretics and calcium-antagonists. Sample comparisons were made with a Xxxxxxx χ2 test for categorical variables using Yate’s correction where appropriate. A Kruskal-Wallis one-way analysis of variance was employed for the comparison of not normally distributed continuous variables such as time intervals. All tests were two-sided, a p-value of < 0.05 was considered significant (using Bonferroni correction where appropriate). All data were analyzed with SPSS 16.0.02. Standardized pre-hospital care of acute myocardial infarction patients 33 A total of 1002 consecutive AMI patients were admitted at the PCI center between 2006 and 2008. Of these patients, 863 (86%) were Xxxxxxxx-Xxxxxx residents and included in the final study population. Baseline characteristics are shown in Table 1. The majority of patients was male (75%) and the mean age was 61 ± 13 years. The distribution of patients from the areas of residence 1, 2, 3 and 4 was 31%, 29%, 21% and 19%, respectively (Fig. 1).
Endpoints. Customers may deploy endpoints of any type (e.g., Windows, MacOS, Linux, Android). There may be a limitation on the number of endpoints that may be deployed depending on the Term of the Traps ELA purchased, as explained in the table below. At purchase or at re-purchase, Customer shall forecast the number of endpoints it expects to add during the Term (“Incremental”). For 1-Year Term/SKU: There is no limit on the number of endpoints that may be deployed. For 3-Year Term/SKU: There is a limit on the number of endpoints that may be deployed: • During the first half of the Term, the cap shall be calculated as follows: Existing endpoints + 150% of Incremental • During the second half of the Term, there is no limit to the number of endpoints that may be deployed. For 5-Year Term/SKU: There is a limit on the number of endpoints deployed, as follows: • During the first 60% of the Term, the cap shall be calculated as follows: Existing endpoints + 150% of Incremental • During the remainder of the Term, there is no limit to the number of endpoints that may be deployed.
Endpoints. During the design of clinical trials, endpoints need to align with the proposed labeling indication which is the desired marketing application. The FDA works with a risk-benefit approach so when the MI agent contains more risk, more benefit needs to be shown. To gain FDA approval for a NDA, the study needs to show direct benefit to the patient or intermediate clinical endpoints that have been shown to predict clinical benefit. For example, if the use of R01-MG- IRDye800 can reduce positive surgical margins, and since positive margins are known to correlate with poor clinical outcome, that would likely be sufficient to demonstrate clinical benefit.22 The same is true for decreased re-operation rate to re-excise breast cancer, or reduced local recurrence in pancreatic cancer. Clinical endpoints in phase II trials should be chosen to mirror the anticipated phase III study so that appropriate power calculations can be established. Furthermore, showing clinical patient benefit at an early stage helps to fund more expensive phase III trials, where the more comprehensive and clinically relevant endpoints are needed.61 For early phase trials sample size justification could range from a formal powered sample size based on clinical outcomes to a sample size with the main justification that the sample size is based on feasibility. The sample size will increase with smaller α and increase for a larger power.60 When the main aim of the study is to determine feasibility, determining the actual sample size is difficult. However, for situations where the intention is that later, more definitive, studies may be carried out, the proper sample size to start with is 12 per group.62 The ICH states that the number of subjects in a clinical trial should always be large enough to provide a reliable answer to the questions addressed. This number is usually determined by the primary objective of the trial. If the sample size is determined on some other basis, as in this case for feasibility studies, this should be made clear and justified.63 For an extensive elaboration on statistical principles for clinical trials, please also see the FDA guidelines.63 In studies in which MI agents are used to identify cancer, histology is crucial to determine the successful targeting of the cancer by the MI agent. Pathohistological assessment is the gold standard to determine whether resected tissue is indeed tumor tissue and these results are correlated to the fluorescent signal. The optimal met...
