Efficacy. When tested against Pseudomonas aeruginosa and Staphylococcus aureus in 2 hours achieves at least a 4.0 log reduction at time zero and a log reduction of 3.0 throughout the shelf life. Reference WI-8.2.4-2.017. • Maintains antimicrobial activity when tested as demonstrated by a 3 day plate to plate CZOI efficacy test against Pseudomonas aeruginosa and Staphylococcus aureus, where a CZ0I of at least 3 mm is maintained. Reference WI-8.2.4-2.034.
Efficacy. Except as specifically provided herein, this Amendment does not in any way waive, amend, modify, affect or impair the terms and conditions of the Purchase Agreement, and all terms and conditions of the Purchase Agreement are hereby ratified and confirmed and shall remain in full force and effect unless otherwise specifically amended, waived, modified or changed pursuant to the terms and conditions of this Amendment. All references in the Purchase Agreement to the term “this Agreement” shall be deemed to refer to the Purchase Agreement referenced in, and as amended by, this Amendment.
Efficacy a. Descriptive statistics for all primary and secondary endpoints
Efficacy. DURATION - CESSATION This contract is valid from to In case the event shall last longer, the present can be extended prior to written agreement among the parties. The event organizer shall communicate to the Agency the reasons for requesting the extension of the present contract. The Agency once assessed these reasons, can grant a time extension or can decide to resolve the present contract without any claim by the organizer. The Agency retains the right to terminate the contract for breach at any time, with the exception of the already completed activities, giving a notice of 30 (thirty) working days. This notice shall be communicated through registered letter.
Efficacy. This License Agreement is valid without Licensor’s signature. It becomes effective upon the Licensee’s first use of the Product.
Efficacy. The Products that result from the practice of the USGN Know-How or the USGN Patent Rights will effectively neutralize or decontaminate the biological and/or chemical substances as set forth in Exhibit C and are fit for the purpose of neutralizing or decontaminating such substances as set forth in Exhibit C.
Efficacy. The preliminary 1-year recurrence-free survival rates overlapped with the results of the RCTs [9, 11, 12]. Even though this is indicative for comparable efficacy, and RFS seems to be a valid surrogate endpoint for overall survival for adjuvant melanoma therapy, it is too soon for conclusions on real-world effectiveness [34]. Xx Xxxx et al. showed comparable 1-year survival rates of 87.0% for the stage IIIA, and 76.5% for stage IIIB, and 60.3% for stage IIIC in a population treated with ICI in Dutch clinical practice [22]. Xxxxxxxx et al. showed a RFS at 1-year of 77.1% after nivolumab and 63.5% after pembrolizumab in a Swiss population [23]. Furthermore, even though Xxxxxxxxxxx et al. showed a 1-year RFS rate of 64.8% in an Austrian population, they showed comparable distant metastasis free-survival compared to the Checkmate-238 trial (77.4% vs. 80%), and concluded treatment cost-effectiveness for the Austrian population [35]. All real-world studies showed comparable effectiveness to the RCTs, which is in line with our premature results. Xxxxxxxx et al. is to our knowledge the only published study reviewing dabrafenib plus trametinib in clinical practice, however they only included three patients who finished their treatment [23].
Efficacy. The primary efficacy variable is the duration (hours) of diarrhea (treatment duration max 5 days). Duration of diarrhea is defined by date of the evacuation of the last diarrheal/watery stool. In order to compare the primary efficacy parameter, duration of diarrhea, between the treatment groups, a Xxxxxx Xxxxx analysis will be performed. The log-rank test will be used to test whether the difference between the duration of diarrhea between two treatment groups is statistically significant, i.e. p-value <0.05. The secondary efficacy variables are • Number of stools at baseline and per treatment day for toilet-trained subjects, only • Number of watery stools per day for toilet-trained subjects, only. • Assessment of treatment success by the physician • Time until recovery, defined by date and time of the evacuation of the first of two consecutive normal stools. • Number of subjects recovered per treatment group, in total and until each individual treatment day • Mean and median time until recovery per treatment group The assessment of treatment success by the physician will be done using the Global Physician Assessment GPA score: 1 = Complete relief of acute diarrhea, 2 = marked improvement of acute diarrhea, 3 = moderate improvement of acute diarrhea, 4 =slight improvement of acute diarrhea, 5 = no change in acute diarrhea, 6 =worsening of acute diarrhea. Treatment will be rated as success when the GPA score equals 1 or 2. Secondary efficacy parameters will be analyzed similarly to the primary analysis. All parameters will also be summarized using descriptive statistics.
Efficacy. The Agreement shall be subject to the approval and confirmation of the Board of Directors of Pag-IBIG Fund and shall be effective from the time of such approval and confirmation.
Efficacy. 5.4.1. Survival Status The primary endpoint of the study is all-cause mortality, therefore the survival status of each subject will be noted at each visit. In the case of subjects who prematurely withdraw from study treatment survival status will be noted at 12-weekly intervals until 156 weeks have elapsed since the subject was randomised to study treatment. See Section 5.7.3 “Long-Term Follow-up of Subjects Withdrawn from Study Treatment”. All deaths occurring during the study treatment period and the long-term follow-up period should also be reported on the paper SAE form and faxed within 24 hours and the SAE entry section in the CRF completed. See Section 7 (AEs and SAEs). In addition, during the long-term follow-up study drug related SAEs should be reported on the paper SAE forms and faxed within 24 hours and the Survival Status Form completed. Accurate assignment of the cause of death is essential and should be done as follows:
