Secondary parameters that support the primary goal of the investigation will be assessed at generally the same intervals as the primary endpoint, with some taken more or less frequently as indicated in detail in Sections 5.2 and 6.1. Additional clinical measurements are also taken during the study that are not considered endpoints for formal analyses, but are to be carefully followed as a part of the study. The schedule for these additional elements is listed in Sections 5.2, 6.2 and 7.2. The secondary variables include the following measures: