Inclusion Criteria:  Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent. Participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (IHC, IF and/or ISH, etc.) analysis.  Exclusion Criteria:  Participants who are considered inappropriate for participation in this study by the research institution.