Blinding. Blinding shall be of the same materials as the hardcore be, crushed and graded from 4 mm upwards, free from clay, chemical or other pollution, pests, weed roots and rubbish.
Blinding. This study is single blind. The participant will be blinded to which study vaccine (MVA-NP+M1 or placebo) they are administered. The Investigator and all study staff acting to determine or record safety, as well as all laboratory staff will also remain blinded (“observer blind”). The pharmacist and any study staff administering the study vaccine will not be blinded. The volume and site of vaccination will be the same for both Group 1 and Group 2. Identical syringes and needles will be used for preparation and administration of each study vaccine. Study vaccine will be prepared out of sight of the participant.
Blinding. Blinding of selected laboratory results is available as an optional service from QLAB. If The Sponsor determines that there is a requirement for blinding of results in this clinical trial, such requirements will be defined in the Scope of Work.
Blinding. Study treatments will be administered in a double-blind fashion (i.e., subjects and site research staff will not know the treatment assigned, with the exception of the dispensing site pharmacist). The central pharmacy, designated TDNCC personnel responsible for creating drug assignment lists, and those involved in DMC report generation in accordance with the DMC Charter will be unblinded. The following study procedures will be in place to ensure double-blind administration of study treatments: Randomization assignments will be stored in a secure database and appropriately protected and backed up Access to the randomization code will be strictly controlled and limited to designated TDNCC personnel who are involved in the generation of the interim report for the Data Safety Monitoring Board (DSMB) GSH and control treatments will be identical in appearance and taste masked with syrup prior to dosing. All dispensed GSH and control treatment bottle packaging and labeling will be identical. During the study, the blind may be broken for individual subjects in emergencies when knowledge of the subject’s treatment group is necessary for further patient management or when the event meets the Food and Drug Administration (FDA) expedited reporting requirements as a suspected adverse reaction that is serious and unexpected (US Code of Federal Regulations (CFR) 21 CFR 312.32(c)(1)(i)). In those cases, knowledge of the treatment received is necessary for interpreting the event. If the blind is broken and the subject was receiving placebo, an IND Safety Report would not be submitted. However, if the blind is broken and the subject is on study drug, an IND Safety Report is submitted to the FDA and all participating investigators would be notified. Emergency un-blinding procedures are provided in the Study Manual (refer to the section on Serious Adverse Experience reporting). The study blind will be broken on completion of the clinical study and after the study database has been locked and study results released. The site investigators will be provided with each subject’s treatment assignment following completion of the statistical report and dissemination of top line results to Sponsor-Investigators.
Blinding. Figure 5. Staged implementation scheme for the 80 participating practices. Numbers indicate the number of practices per wave. Actual accrual pace may vary. Ideally, participants, practices and data collectors as well as any study staff interacting with participants should be blinded to the practice’s randomization status in order to minimize biases. However, in many trials of behavior change interventions like this one, this is not possible. Nevertheless, we will implement blinding where feasible. Data collectors will be separated from research team members engaged in intervention implementation. Patients in the enhanced usual care and practice facilitation-only arms will be blinded to the practice’s randomization status. However, it will not be possible to blind practices to their randomization status, and it will not be possible to blind patients in the peer coaching arms to the practice’s randomization status.
Blinding. In this double-blind study all patients, investigators, site personnel, laboratories and central readers with direct involvement in the conduct of the study or their designees will be blinded to treatment assignments. To prevent potential bias, appropriate measures will be taken to ensure the blind is maintained for the patients and personnel mentioned previously. To maintain the blind, investigators will distribute blinded study drug treatment kits to patients as directed by the IWRS system. Investigators and patients will not be blinded to dose level, but will be blinded to treatment assignment (i.e., active study drug vs. placebo). An IWRS system will manage treatment assignments. The only people with direct access to treatment assignments will be those individuals who develop and maintain the randomization code, the DSMB and the statistical group reporting to the DSMB.
Blinding. The site investigators and patients are blinded to treatment assignment during the conduct of the study. All study staff will be blinded to the treatment assignments and study drug will be administered in a blinded manner. Unblinding of treatment assignments should be undertaken for safety reasons when it is essential for effective treatment of the patient. Unblinding is performed using the IRT. When the investigator contacts the IRT to unblind a patient, he/she must provide the requested patient identifying information and confirm the necessity to unblind the patient. The Investigator will then receive details of the drug treatment for the specified patient. The entire study population will be unblinded at the end of the study and the unblinding information will be shared with each study site.
Blinding. RCC analysts and other staff at the RCC were blinded to histology results, and pathologists were blinded to imaging results. RCC analysts were blinded to treatment assignment. Other data Subject demographics, laboratory, anthropomorphic measurements, and medical history ACCEP XXX XXXXX CRIP T were collected at each clinical trial site. Statistical analysis Statistical analyses were done with SAS (SAS Institute 2011, Base SAS 9·3 Procedures Guide) and Stata (StataCorp 2013, Stata Statistical Software: release 13). A single PDFF value was calculated for each MRI exam as the mean of the PDFF values for the nine anatomical liver segments. Demographic, histologic and imaging information were summarized with categorical variables expressed as numbers and percentages and continuous variables expressed by mean (± standard deviation [SD]). The proportion of subjects who had, vs did not have MRIs at baseline was compared with regard to treatment group, study site, demographics, liver enzymes, lipids, metabolic factors, co-morbidities, concomitant liver medications, and histology findings. Xxxxxxx partial correlation coefficients and 95% confidence intervals were estimated between PDFF and histologic variables (steatosis, lobular inflammation, hepatocellular ballooning, fibrosis, and portal inflammation) at baseline and for changes from baseline to 72 weeks. Diagnostic accuracy of PDFF to classify hepatic steatosis grade at baseline was tested for grades 0-1 vs 2-3, and grades 0-2 vs 3. Diagnostic accuracy of change in PDFF to classify change in hepatic steatosis grade from baseline to EOT was tested for: reduction vs no change/increase and increase vs no change/decrease. Cross-validated area under ROC (AUROC) curves using a jack-knife procedure and 95% CIs were estimated for each of these dichotomizations [26]. Cut-off PDFF values were estimated using the lowest threshold value for which there was ≥ 90% specificity to distinguish between these dichotomized categories. Sensitivity, positive predictive values (PPVs), and negative predictive valves (NPVs) were calculated along with 95% confidence intervals (CIs) fixing specificity at 90%. ACCEP XXX XXXXX CRIP T RESULTS Of 283 adults enrolled in the FLINT trial from March 16, 2011 to December 3, 2012 at eight participating FLINT clinical trial sites, 113 (40%) had MRI and liver biopsy at baseline, 85 (30%) had MRI and liver biopsy at EOT, and 78 (28%) had MRI and liver biopsy at both time points. One subject with a base...
Blinding. Articles will be blinded by removing author names and affiliation lists from every PDF. Number of the raters Each blinded publication has 2 raters, the ratings were conducted independently. Sample size From 192 publications, we have 96 articles for the case group and 96 articles for the control group. See Figure 3.1 No sample size calculation has been done. The publications are given by the output of the group in the years 2017 and 2018. Definition of case and control publications The case group are all medical research publications from PubMed between 2017 and 2018 with at least one of the biostatisticians as main or co-author was retrieved on Dec 9, 2019 (cases). The control group are all medical research publications found in PubMed between 2017 and 2018, with affiliation University of Zurich or University Hospital Zurich or any of the affiliated university hospitals for first and / or second author were extracted (denoted as "potential controls") on Dec 16, 2019. This large number of publications will be used in a random but replicable order aiming to remove potential chronological ordering or any other systematic ordering while adhering to high standards of reproducibility. Statistical methods and programming All statistical programming will be performed with R, in combination with dynamic report- ing. Statistical programming included downloading all potential control publications, random reordering, development of a shiny app for categorization of the publications, development of a shiny app for quality rating of the publications, as well as statistical methods for comparison of case and control group, and its graphical display. We agree that Interrater reliability and agreement examinations are needed to estimate the amount of error in the rating or scoring of tests and classification procedures. such that: Reliability is ability of a measurement to differentiate between subjects (here the articles). Agreement is the degree to which scores or ratings are identical. Both concepts are important, because they provide us information about the quality of measurements in this study. For assessing the level of agreement of reporting quality between the two raters, kappas values, ICC will be estimated. Low levels of agreement would indicate that the ratings are complex and that third party arbitration was required in many publications.
Blinding. This is an open-label study and therefore the clinical drug supplies are not blinded.
