Analysis of study data will be conducted to address all objectives of the trial and other interrelationships among all data elements of interest to the investigators and of relevance to the objectives of the study. Primary analysis of treatment effect will be conducted under the intention-to-treat (ITT) principle of eligible patients, whereby outcome data from all eligible patients will be included regardless of treatment compliance. In addition to the analyses described in sections below, summary descriptive statistics will be provided in the following manner: continuous data will be summarized descriptively by mean, standard deviation, median, and range; categorical data will be presented as enumerations and percentages.