Analysis Populations. Intent-to-treat (ITT) and safety populations: All subjects who are randomized, take one or more doses and have at least one post dosing assessment will be included in the ITT and safety populations.
Analysis Populations. The following analysis populations will be used:
Analysis Populations. The population valid for the safety analysis will be comprised of all patients who received treatment with IRE. Patients who received at least one treatment with IRE will be valid for safety analysis.
Analysis Populations. The modified intent-to-treat population (mITT) is defined as all subjects who are randomized, receive study drug for at least 8 weeks, and have a baseline and at least 1 post-baseline MRI- PDFF assessment on or after Week 8. The mITT is the primary population for analysis of MRI- PDFF assessments and subjects will be analyzed according to the randomized treatment assignment. The intent-to-treat population (ITT) is defined as all subjects who are randomized and received at least 1 dose of study drug. The ITT will be used for analysis of secondary efficacy endpoints and supportive and sensitivity analyses of MRI-PDFF assessments. Subjects will be analyzed according to the randomized treatment assignment. Details will be provided in the Statistical Analysis Plan (SAP). The safety population is defined as all subjects who are randomized and received at least 1 dose of study drug and will be used for all analysis of safety. Subjects will be analyzed according to the treatment received. If all subjects were dosed according to randomized treatment assignment, then the safety population and ITT are identical.
Analysis Populations. Three different analysis populations will be used for analysis of data from this study, as described below: • Randomized: This population will be comprised of all subjects who were initially randomized. This population will be used for summaries of subject disposition and baseline subject characteristics. • Intent-to-treat (ITT)/Safety: This population will be comprised of all subjects who were initially randomized and received at least one dose of study drug. This will be the primary population for all summaries of subject disposition and baseline characteristics, efficacy analyses, and safety analyses for purposes of regulatory submissions. • Modified Intent-to Treat (m-ITT): This population will be comprised of all randomized study subjects who receive study treatment and return for at least one post-randomization assessment of height and weight. This population will be used for the analysis of all efficacy variables for all other purposes, including but not limited to publications, presentations, and robustness of sensitivity of analyses.
Analysis Populations. The Total Population will comprise all subjects screened and for whom a record exists on the study database. The Safety population will consist of all subjects who were randomised to treatment and who received at least one dose of trial medication. Randomised subjects will be assumed to have received trial medication unless definitive evidence exists to the contrary. If any subjects have inadvertently received a different treatment for the duration of the study, or were inadvertently given more than one treatment, their data will be assigned to the treatment group to which they took for the majority (i.e. >50%) of the treatment period. This population will form the primary population for analyses of safety data The Intent-to-Treat – Efficacy (ITT) population will consist of all subjects in the Safety Population, with the exception of subjects recruited at sites which were closed down as the result of audit findings or other information which implied that the integrity of the data had been compromised. These subjects will be excluded from the ITT population (and all efficacy analyses), and this decision will be formally documented prior to unblinding of the trial.. The ITT Population follows the intention-to-treat principles defined in the ICH E9 guidelines [The European Agency for the Evaluation of Medicinal Products, 1998]. Following these principles, if any subjects have inadvertently received a different treatment for the duration of the study, or were inadvertently given more than one treatment, their data will be assigned to the treatment group to which they were originally randomised, irrespective of which treatment they actually took. This population will form the primary population for analysis of efficacy measures, including mortality, and for analyses of health outcomes measures. The Health Outcomes Population will be a subset of the Intent-to-Treat – Efficacy Population, and will consist of subjects participating in countries where SGRQ questionnaire translations are linguistically valid for the population, and who have completed at least one questionnaire. If any subjects have inadvertently received a different treatment for the duration of the study, or were inadvertently given more than one treatment, their data will be assigned to the treatment group to which they were originally randomised, irrespective of which treatment they actually took. This population will be used for all analyses and listings pertaining to health outcomes related to ...
Analysis Populations. The Safety Population will include all subjects who receive at least 1 dose of study drug. The PK Population will include subjects who receive study drug and have sufficient concentration data to facilitate the calculation of PK variables.
Analysis Populations
