Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/identificationModule/briefTitle",
"value": "A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy"
},
{
"op": "replace",
"path": "/protocolSection/identificationModule/officialTitle",
"value": "A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy"
},
{
"op": "add",
"path": "/protocolSection/identificationModule/acronym",
"value": "SANDPIPER"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2017-05"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/startDateStruct/date",
"value": "2015-04-09"
},
{
"op": "add",
"path": "/protocolSection/statusModule/startDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2018-07-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2018-07-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2017-05-15"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2017-05-16"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/briefSummary",
"value": "This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy.\nThere will be a 2:1 randomization to the taselisib arm versus the placebo arm.\nEnrollment will be enriched for participants with PIK3CA mutant tumors via central testing.\nThe anticipated duration of the study is approximately 3.5 years."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
"value": "Taselisib + Fulvestrant"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
"value": "Drug: Taselisib"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
"value": "Drug: Fulvestrant"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
"value": "Participants will receive taselisib 4 milligrams (mg) orally (PO) once daily (QD) beginning at Cycle 1, Day 1 and fulvestrant 500 mg intramuscular (IM) injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle, until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
"value": "Placebo + Fulvestrant"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/type",
"value": "PLACEBO_COMPARATOR"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
"value": "Drug: Placebo"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
"value": "Drug: Fulvestrant"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
"value": "Participants will receive placebo matching to taselisib PO QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle, until disease progression, unacceptable toxicity, or study termination by the Sponsor."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/name",
"value": "Taselisib"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/description",
"value": "Taselisib 4 mg will be administered as two tablets of 2 mg each as per the schedule specified in the respective arm."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
"value": "Taselisib + Fulvestrant"
},
{
"op": "remove",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/0",
"value": "GDC-0032, RO5537381"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/name",
"value": "Placebo"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/description",
"value": "Placebo matching to taselisib will be administered as per the schedule specified in the respective arm."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
"value": "Placebo + Fulvestrant"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/2/name",
"value": "Fulvestrant"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/2/description",
"value": "Fulvestrant 500 mg will be administered as two IM injections of 250 mg each as per the schedule specified in the respective arms."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0",
"value": "Placebo + Fulvestrant"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1",
"value": "Taselisib + Fulvestrant"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/2/otherNames/0",
"value": "Faslodex"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "From randomization until the first occurence of disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Overall Survival"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "From randomization up to death from any cause (up to approximately 3.5 years)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "From randomization until the first occurence of disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "From randomization until the first occurence of disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Clinical benefit is defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "Time from the first occurence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "From randomization until the first occurence of disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
"value": {
"measure": "Pecentage of Participants With Adverse Events",
"timeFrame": "From randomization up to approximately 3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6",
"value": {
"measure": "Maximum Observed Plasma Concentration (Cmax) of Taselisib",
"timeFrame": "1 to 4 hours (hrs) post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7",
"value": {
"measure": "Minimum Observed Plasma Concentration (Cmin) of Taselisib",
"timeFrame": "1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8",
"value": {
"measure": "European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score",
"timeFrame": "Day 1 of each 28-day Cycle up to 12 weeks after disease progression (up to approximately 3.5 years)"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/9",
"value": {
"measure": "Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score",
"timeFrame": "Day 1 of each 28-day Cycle up to 12 weeks after disease progression (up to approximately 3.5 years)"
}
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria:</p><ul><li>Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic ER positive breast cancer</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1</li><li>Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study</li><li>Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer</li><li>Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an AI, or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer</li><li>Measurable disease via RECIST v1.1 or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1</li><li>Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for PIK3CA-mutation testing</li><li>A valid cobas PIK3CA mutation result by central testing is required</li><li>Adequate hematologic and end-organ function within 28 days prior to treatment initiation</li></ul><p>Exclusion Criteria:</p><ul><li>HER2-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)</li><li>Prior treatment with fulvestrant</li><li>Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g.\neverolimus), or protein kinase B (AKT) inhibitor</li><li>Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1</li><li>Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1</li><li>All acute treatment-related toxicity must have resolved to Grade less than or equal to (</=) 1 or be deemed stable by the Investigator</li><li>Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer</li><li>Concurrent hormone replacement therapy</li><li>Known untreated or active central nervous system (CNS) metastases</li><li>Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications</li><li>History of inflammatory bowel disease or active bowel inflammation</li><li>Clinically significant cardiac or pulmonary dysfunction</li><li>Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus</li></ul>"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/centralContacts/0/email",
"value": "global-roche-genentech-trials@gene.com"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/0/status",
"value": "WITHDRAWN"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/0/city",
"value": "Birmingham"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/0/state",
"value": "Alabama"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/0/zip",
"value": "35226"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/0/geoPoint/lat",
"value": 33.52066
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/0/geoPoint/lon",
"value": -86.80249
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/facility",
"value": "University of Alabama"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/1/status",
"value": "WITHDRAWN"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/1/city",
"value": "Scottsdale"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/1/zip",
"value": "85258"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/1/geoPoint/lat",
"value": 33.50921
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/1/geoPoint/lon",
"value": -111.89903
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/1/facility",
"value": "HonorHealth Research Institute - Pima Center"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/2/city",
"value": "Tucson"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/2/state",
"value": "Arizona"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/2/zip",
"value": "85704"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/2/geoPoint/lat",
"value": 32.22174
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/2/geoPoint/lon",
"value": -110.92648
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/2/facility",
"value": "Arizona Oncology"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/3/city",
"value": "Tucson"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/3/state",
"value": "Arizona"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/3/zip",
"value": "85710"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/3/geoPoint/lat",
"value": 32.22174
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/3/geoPoint/lon",
"value": -110.92648
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/3/facility",
"value": "Arizona Oncology Associates, P.C."
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/4/city",
"value": "Santa Ana"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/4/state",
"value": "California"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/4/zip",
"value": "92705"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/4/geoPoint/lat",
"value": 33.74557
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/4/geoPoint/lon",
"value": -117.86783
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/4/facility",
"value": "Breastlink Medical Group Inc; Research"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/5/city",
"value": "Atlanta"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/5/state",
"value": "Georgia"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/5/zip",
"value": "30341"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/5/geoPoint/lat",
"value": 33.749
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/5/geoPoint/lon",
"value": -84.38798
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/5/facility",
"value": "Georgia Cancer Specialists - Northside"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/6/status",
"value": "ACTIVE_NOT_RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/6/city",
"value": "Marietta"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/6/state",
"value": "Georgia"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/6/zip",
"value": "30060"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/6/geoPoint/lat",
"value": 33.9526
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/6/geoPoint/lon",
"value": -84.54993
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/6/facility",
"value": "Northwest Georgia Oncology Centers"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/7/status",
"value": "WITHDRAWN"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/7/city",
"value": "Chicago"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/7/state",
"value": "Illinois"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/7/zip",
"value": "60611"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/7/geoPoint/lat",
"value": 41.85003
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/7/geoPoint/lon",
"value": -87.65005
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/7/facility",
"value": "Northwestern Univ. Medical Schoo; Hematology/Oncology Division"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/8/city",
"value": "Harvey"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/8/state",
"value": "Illinois"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/8/zip",
"value": "60426"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/8/geoPoint/lat",
"value": 41.61003
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/8/geoPoint/lon",
"value": -87.64671
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/8/facility",
"value": "Ingalls Hospital"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/9/city",
"value": "Westminster"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/9/state",
"value": "Maryland"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/9/zip",
"value": "21157"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/9/geoPoint/lat",
"value": 39.57538
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/9/geoPoint/lon",
"value": -76.99581
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/9/facility",
"value": "Maryland Oncology Hematology"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/10/status",
"value": "ACTIVE_NOT_RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/10/city",
"value": "Boston"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/10/state",
"value": "Massachusetts"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/10/zip",
"value": "02215"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/10/geoPoint/lat",
"value": 42.35843
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/10/geoPoint/lon",
"value": -71.05977
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/10/facility",
"value": "Dana Farber Can Ins"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/11/city",
"value": "Minneapolis"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/11/state",
"value": "Minnesota"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/11/zip",
"value": "55407-3799"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/11/geoPoint/lat",
"value": 44.97997
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/11/geoPoint/lon",
"value": -93.26384
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/11/facility",
"value": "Abbott Northwestern Hospital; Virginia Piper Cancer Center"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/12/city",
"value": "Ballwin"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/12/state",
"value": "Missouri"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/12/zip",
"value": "63011"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/12/geoPoint/lat",
"value": 38.59505
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/12/geoPoint/lon",
"value": -90.54623
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/12/facility",
"value": "Mercy Clinic: St. Louis Cancer and Breast Institute- Ballwin"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/13/status",
"value": "RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/13/city",
"value": "St Louis"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/13/state",
"value": "Missouri"
},
{
"op": "replace",
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{
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{
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{
"op": "add",
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},
{
"op": "replace",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/65/city",
"value": "Zhengzhou"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/65/zip",
"value": "450008"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/65/country",
"value": "China"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/65/geoPoint/lat",
"value": 34.75778
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/65/geoPoint/lon",
"value": 113.64861
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{
"op": "add",
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"value": "Henan Cancer Hospital"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/66/city",
"value": "Bogotá"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/66/zip",
"value": "11001"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/66/country",
"value": "Colombia"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/66/geoPoint/lat",
"value": 4.60971
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/66/geoPoint/lon",
"value": -74.08175
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{
"op": "add",
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"value": "Clinica del Country"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/67/status",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/67/city",
"value": "Bogotá"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/67/zip"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/67/country",
"value": "Colombia"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/67/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/67/geoPoint/lon",
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{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/68/city",
"value": "Medellín"
},
{
"op": "remove",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/68/country",
"value": "Colombia"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/68/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/68/geoPoint/lon",
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{
"op": "add",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/69/city",
"value": "Montería"
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{
"op": "remove",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/69/country",
"value": "Colombia"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/69/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/69/geoPoint/lon",
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{
"op": "add",
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"value": "Oncomedica S.A."
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/70/status",
"value": "COMPLETED"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/70/city",
"value": "Hradec Králové"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/70/zip",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/70/country",
"value": "Czechia"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/70/geoPoint/lat",
"value": 50.20923
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/70/geoPoint/lon",
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{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/70/facility",
"value": "University Hospital; Oncology and Radiotherapy"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/71/status",
"value": "RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/71/city",
"value": "Olomouc"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/71/zip",
"value": "779 00"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/71/country",
"value": "Czechia"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/71/geoPoint/lat",
"value": 49.59552
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/71/geoPoint/lon",
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{
"op": "add",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/72/city",
"value": "Pardubice"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/72/zip",
"value": "532 03"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/72/country",
"value": "Czechia"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/72/geoPoint/lat",
"value": 50.04075
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/72/geoPoint/lon",
"value": 15.77659
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{
"op": "add",
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"value": "Multiscan s.r.o."
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/73/status",
"value": "RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/73/city",
"value": "Prague"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/73/zip",
"value": "128 08"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/73/country",
"value": "Czechia"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/73/geoPoint/lat",
"value": 50.08804
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/73/geoPoint/lon",
"value": 14.42076
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{
"op": "add",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/74/status",
"value": "RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/74/city",
"value": "Sädesairaala"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/74/zip",
"value": "70210"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/74/country",
"value": "Finland"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/74/geoPoint"
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{
"op": "add",
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"value": "KYS Sädesairaala"
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{
"op": "replace",
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"value": "Tampere"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/75/zip",
"value": "33520"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/75/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/75/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/75/geoPoint/lon",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/76/city",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/76/zip",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/76/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/76/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/76/geoPoint/lon",
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{
"op": "add",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/77/status",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/77/city",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/77/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/77/geoPoint/lon",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/78/zip",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/78/country",
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{
"op": "replace",
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{
"op": "replace",
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"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/79/country",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/80/country",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/81/country",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/82/country",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/84/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/84/geoPoint/lat",
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{
"op": "replace",
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"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/85/city",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/85/country",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/86/city",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/86/zip",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/86/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/86/geoPoint/lat",
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{
"op": "replace",
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{
"op": "add",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/87/city",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/87/zip",
"value": "67000"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/87/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/87/geoPoint/lat",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/88/status",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/88/city",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/88/zip",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/88/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/88/geoPoint/lat",
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{
"op": "replace",
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{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/89/zip",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/89/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/89/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/89/geoPoint/lon",
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{
"op": "add",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/90/city",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/90/zip",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/90/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/90/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/90/geoPoint/lon",
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{
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{
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"path": "/protocolSection/contactsLocationsModule/locations/114/country",
"value": "Italy"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/114/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/114/geoPoint/lon",
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{
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{
"op": "add",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/115/city",
"value": "Pontedera"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/115/zip",
"value": "56025"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/115/country",
"value": "Italy"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/115/geoPoint/lat",
"value": 43.66141
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/115/geoPoint/lon",
"value": 10.63067
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{
"op": "add",
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{
"op": "add",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/116/status",
"value": "ACTIVE_NOT_RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/116/city",
"value": "Mestre"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/116/zip",
"value": "30174"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/116/country",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/116/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/116/geoPoint/lon",
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{
"op": "add",
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},
{
"op": "add",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/117/city",
"value": "Padova"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/117/zip",
"value": "35012"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/117/country",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/117/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/117/geoPoint/lon",
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{
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{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/117/state",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/118/city",
"value": "D.f."
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/118/zip",
"value": "04980"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/118/country",
"value": "Mexico"
},
{
"op": "remove",
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},
{
"op": "add",
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},
{
"op": "replace",
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"value": "RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/119/city",
"value": "Distrito Federal"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/119/zip",
"value": "14000"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/119/country",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/119/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/119/geoPoint/lon",
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{
"op": "add",
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{
"op": "replace",
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"value": "WITHDRAWN"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/120/city",
"value": "La Raza"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/120/zip",
"value": "02990"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/120/country",
"value": "Mexico"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/120/geoPoint/lat",
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{
"op": "replace",
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{
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/121/zip",
"value": "03100"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/121/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/121/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/121/geoPoint/lon",
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{
"op": "add",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/122/city",
"value": "Monterrey"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/122/zip",
"value": "64020"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/122/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/122/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/122/geoPoint/lon",
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{
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/123/city",
"value": "Oaxaca City"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/123/zip",
"value": "68000"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/123/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/123/geoPoint/lat",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/124/zip",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/124/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/124/geoPoint/lat",
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{
"op": "replace",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/125/city",
"value": "Arnhem"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/125/zip",
"value": "6815 AD"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/125/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/125/geoPoint/lat",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/125/geoPoint/lon",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/126/city",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/126/zip",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/126/country",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/127/zip",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/127/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/127/geoPoint/lat",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/128/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/128/geoPoint/lat",
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{
"op": "replace",
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{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/129/city",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/129/zip",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/129/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/129/geoPoint/lat",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/130/city",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/130/zip",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/130/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/130/geoPoint/lat",
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{
"op": "replace",
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"op": "add",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/131/country",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/132/zip",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/132/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/132/geoPoint/lat",
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{
"op": "replace",
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{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/133/city",
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{
"op": "replace",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/133/country",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/133/geoPoint/lat",
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{
"op": "replace",
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},
{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/134/zip",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/134/country",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/135/country",
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{
"op": "replace",
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{
"op": "replace",
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{
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/136/city",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/136/zip",
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},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/136/country",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "remove",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "add",
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{
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/138/country",
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{
"op": "replace",
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{
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/139/country",
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{
"op": "replace",
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{
"op": "replace",
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