 13. Developed acute upper gastrointestinal bleeding, gastric ulcer a mucosal defect with white coating or duodenal ulcer a mucosal defect with white coating, within 30 days before the start of the Screening Phase Visit 1 with the possible inclusion of those with gastric or duodenal erosion. Participants requiring non-steroidal anti-inflammatory drugs NSAIDs or aspirin treatment along with the concomitant PPI therapy to prevent gastrointestinal GI bleeding should not be enrolled. 