CONFIDENTIALITY AGREEMENTCaliber Study • August 26th, 2023
Study Groups (after 6-month evaluations) After completion of the 6-month follow-up visit, subjects assigned to the double-dose PPI arm will:1.) Have their PPI dose stepped-down to single-dose (Omeprazole 20 mg daily) and continued until the 12 month visit, unless symptoms return and double-dose PPIs are restartedOR2.) Have the option to cross-over to LINX if cross-over criteria are metSee Figure 1 Cross-Over Criteria (after 6 month evaluations) The following criteria must be met for cross-over to LINX:• Abnormal total number of distal reflux episodes as assessed by the 6-month impedance testing completed on double-dose PPIs• Presence of moderate or severe regurgitation reported on the 6- month Foregut Symptom Questionnaire completed on double- dose PPIs• Patient consents to LINX procedure Primary Endpoint and Additional Effectiveness Measures Primary EndpointPercentage of subjects treated with LINX compared to percentage of subjects treated with double-dose PPIs who have elimination
