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NCT00490139

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

Version 8 to 9 · Novartis Pharmaceuticals

Patch inspector

Version 8 to 9

417 operations 4 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
eligibility_criteria_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:00:57+00
Raw hash
ba314c502ed4992c2bb5f46e68b165d9a7f5989e31515a69cf793d28e6f12211
Payload
Source URL
Eligibility Criteria and population definition changes. Triage: High 1 ops
replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
Eligibility Change Operation 7
Matched rules
  • eligibility_criteria_change Eligibility criteria changes can alter the studied population.
Before
<p>INCLUSION CRITERIA:</p><ul><li>Age ≥ 18 years</li><li>Eastern Cooperative Oncology Group (ECOG) performance status ≥1;</li><li><p>Non-metastatic operable primary invasive adenocarcinoma of the breast fulfilling the following:</p><ol><li>Histologically confirmed;</li><li>Adequately excised (exceptions: patients who have &#x27;non-resectable&#x27; deep margin invasion are eligible provided they have had or will receive radiotherapy encompassing the region concerned; patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumour bed);</li><li>Axilla dissected; sentinel node sampling is allowed provided that axillary dissection follows confirmation of a positive sentinel node; sentinel node sampling alone is NOT acceptable after neoadjuvant chemotherapy (in patients receiving neoadjuvant chemotherapy lymph node status will be considered unknown, regardless of the results of post-chemotherapy axillary dissection);</li><li>Axillary node positive patient OR node negative patient with a tumour greater than or equal to 1.0 cm in greatest diameter (³ T1c) according to TNM.</li></ol></li><li>Known hormone receptor status (ER&#x2F;PgR or ER alone);</li><li>Must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen (see Table 5).</li></ul><p>For design 1: Randomisation must be performed no longer than 12 weeks from day 1 of the last chemotherapy cycle after obtaining a post-chemotherapy LVEF ≥ 50.
Study treatment should start no more than 14 days after randomisation.</p><p>For design 2: Randomisation must be performed no longer than 6 weeks from day 1 of the last anthracycline-containing chemotherapy cycle after obtaining a post-anthracycline chemotherapy LVEF ≥ 50.
Study treatment should start no more than 14 days after randomization and must be concurrent with paclitaxel.</p><ul><li>Baseline LVEF ³50% measured by echocardiography or MUGA scan after completion of all anthracycline-based (neo-) adjuvant chemotherapy and prior to the targeted therapy(ies).</li><li>Over expression and&#x2F;or amplification of HER2 in the invasive component of the primary tumour (in case of neoadjuvant treatment, tissue sample used for HER2 testing should be collected before neoadjuvant treatment starts), according to one of the following definitions [Wolff et al 2007] and confirmed by central laboratory prior to randomisation:</li><li>3+ over expression by IHC (&gt; 30% of invasive tumour cells);</li><li>2+ or 3+ (in 30% or less neoplastic cells) over expression by IHC AND in situ hybridization (FISH&#x2F;CISH) test demonstrating HER2 gene amplification;</li><li>HER2 gene amplification by FISH&#x2F;CISH ( &gt; 6 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of &gt; than 2.2.) Patients with a negative or equivocal overall result (FISH test ratio of &lt; 2.2, &lt; 6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.</li></ul><p>Equivocal local results may be submitted for a final determination by the central laboratory.</p><ul><li>Completion of all necessary baseline laboratory and radiological investigations (see section 6.1);</li><li>Signed written informed consent (approved by an Independent Ethics Committee (IEC) and obtained prior to any study specific screening procedures).</li></ul><p>EXCLUSION CRITERIA:</p><ul><li>History of any prior (ipsi- and&#x2F;or contralateral) invasive breast carcinoma;</li><li>Past or current history of malignant neoplasms, except for curatively treated: - Basal and squamous cell carcinoma of the skin;- Carcinoma in situ of the cervix</li><li>Any clinically staged T4 tumour, including inflammatory breast cancer;</li><li>Bilateral tumours;</li><li>Multifocal tumours;</li><li>Maximum cumulative dose of doxorubicin &gt;360mg&#x2F;m² or maximum cumulative dose of epirubicin &gt;720mg&#x2F;m² or any prior anthracyclines unrelated to the present breast cancer;</li><li>(Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support;</li><li>Any prior mediastinal irradiation except internal mammary node irradiation for the present breast cancer;</li><li>Patients with positive or suspicious internal mammary nodes identified by sentinel node technique which have not been irradiated or will not be irradiated, or patients with supraclavicular lymph node involvement (confirmed by fine needle aspirate or biopsy);</li><li>Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for breast cancer;</li><li>Concurrent anti-cancer treatment, except hormonal therapy;</li><li>Concurrent anti-cancer treatment in another investigational trial with hormone therapy or immunotherapy:</li><li>Serious cardiac illness or medical conditions including but not confined to:</li></ul><p>History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF &lt;50%); High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled); Angina pectoris requiring antianginal medication; Clinically significant valvular heart disease; Evidence of transmural infarction on ECG; Poorly controlled hypertension (e.g.
systolic &gt;180mm Hg or diastolic &gt;100mm Hg);</p><ul><li>Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions&#x2F;illness;</li><li>Any of the following abnormal laboratory tests immediately prior to randomisation:</li></ul><p>serum total bilirubin &gt;2.0 x upper limit of normal (ULN); alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) &gt;2.5 x ULN; alkaline phosphatase (ALP) &gt; 2.5 x ULN; serum creatinine &gt;2.0 x ULN; total white blood cell count (WBC) &lt;2.5 x 109&#x2F;L; absolute neutrophil count &lt;1.5 x 109&#x2F;L; platelets &lt;100 x 109&#x2F;L.</p><ul><li>Unresolved or unstable serious adverse events from prior adjuvant chemotherapy or radiotherapy;</li><li>Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication.
Subjects with ulcerative colitis are also excluded;</li><li>Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test - urine or serum - within 7 days prior to randomisation);</li><li>Women of childbearing potential and male participants with partners of child bearing potential, including women whose last menstrual period was &lt;1 year ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment (adequate contraceptive measures: intra-uterine device, barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence.
Oral, injectable, or implant hormonal contraceptives are not indicated in this patient population);</li><li>Concomitant use of CYP3A4 inhibitors or inducers.
See section 5.3.2 for list of medications.</li></ul>
After
<p>INCLUSION CRITERIA:</p><ul><li>Age ≥ 18 years</li><li>Eastern Cooperative Oncology Group (ECOG) performance status ≥1;</li><li><p>Non-metastatic operable primary invasive adenocarcinoma of the breast fulfilling the following:</p><ol><li>Histologically confirmed;</li><li>Adequately excised (exceptions: patients who have &#x27;non-resectable&#x27; deep margin invasion are eligible provided they have had or will receive radiotherapy encompassing the region concerned; patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumour bed);</li><li>Axilla dissected; sentinel node sampling is allowed provided that axillary dissection follows confirmation of a positive sentinel node; sentinel node sampling alone is NOT acceptable after neoadjuvant chemotherapy (in patients receiving neoadjuvant chemotherapy lymph node status will be considered unknown, regardless of the results of post-chemotherapy axillary dissection);</li><li>Axillary node positive patient OR node negative patient with a tumour greater than or equal to 1.0 cm in greatest diameter (≥ T1c) according to TNM.</li></ol></li><li>Known hormone receptor status (ER&#x2F;PgR or ER alone);</li><li>Must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen.</li></ul><p>For design 1: Randomisation must be performed no longer than 12 weeks from day 1 of the last chemotherapy cycle after obtaining a post-chemotherapy LVEF ≥ 50.
Study treatment should start no more than 14 days after randomisation.</p><p>For design 2: Randomisation must be performed no longer than 6 weeks from day 1 of the last anthracycline-containing chemotherapy cycle after obtaining a post-anthracycline chemotherapy LVEF ≥ 50.
Study treatment should start no more than 14 days after randomization and must be concurrent with paclitaxel.</p><ul><li>Baseline LVEF ≥50% measured by echocardiography or MUGA scan after completion of all anthracycline-based (neo-) adjuvant chemotherapy and prior to the targeted therapy(ies).</li><li>Over expression and&#x2F;or amplification of HER2 in the invasive component of the primary tumour (in case of neoadjuvant treatment, tissue sample used for HER2 testing should be collected before neoadjuvant treatment starts), according to one of the following definitions [Wolff et al 2007] and confirmed by central laboratory prior to randomisation:</li><li>3+ over expression by IHC (&gt; 30% of invasive tumour cells);</li><li>2+ or 3+ (in 30% or less neoplastic cells) over expression by IHC AND in situ hybridization (FISH&#x2F;CISH) test demonstrating HER2 gene amplification;</li><li>HER2 gene amplification by FISH&#x2F;CISH ( &gt; 6 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of &gt; than 2.2.) Patients with a negative or equivocal overall result (FISH test ratio of &lt; 2.2, &lt; 6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.</li></ul><p>Equivocal local results may be submitted for a final determination by the central laboratory.</p><ul><li>Completion of all necessary baseline laboratory and radiological investigations</li><li>Signed written informed consent (approved by an Independent Ethics Committee (IEC) and obtained prior to any study specific screening procedures).</li></ul><p>EXCLUSION CRITERIA:</p><ul><li>History of any prior (ipsi- and&#x2F;or contralateral) invasive breast carcinoma;</li><li>Past or current history of malignant neoplasms, except for curatively treated: - Basal and squamous cell carcinoma of the skin;- Carcinoma in situ of the cervix</li><li>Any clinically staged T4 tumour, including inflammatory breast cancer;</li><li>Bilateral tumours;</li><li>Multifocal tumours;</li><li>Maximum cumulative dose of doxorubicin &gt;360mg&#x2F;m² or maximum cumulative dose of epirubicin &gt;720mg&#x2F;m² or any prior anthracyclines unrelated to the present breast cancer;</li><li>(Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support;</li><li>Any prior mediastinal irradiation except internal mammary node irradiation for the present breast cancer;</li><li>Patients with positive or suspicious internal mammary nodes identified by sentinel node technique which have not been irradiated or will not be irradiated, or patients with supraclavicular lymph node involvement (confirmed by fine needle aspirate or biopsy);</li><li>Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for breast cancer;</li><li>Concurrent anti-cancer treatment, except hormonal therapy;</li><li>Concurrent anti-cancer treatment in another investigational trial with hormone therapy or immunotherapy:</li><li>Serious cardiac illness or medical conditions including but not confined to:</li></ul><p>History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF &lt;50%); High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled); Angina pectoris requiring antianginal medication; Clinically significant valvular heart disease; Evidence of transmural infarction on ECG; Poorly controlled hypertension (e.g.
systolic &gt;180mm Hg or diastolic &gt;100mm Hg);</p><ul><li>Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions&#x2F;illness;</li><li>Any of the following abnormal laboratory tests immediately prior to randomisation:</li></ul><p>serum total bilirubin &gt;2.0 x upper limit of normal (ULN); alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) &gt;2.5 x ULN; alkaline phosphatase (ALP) &gt; 2.5 x ULN; serum creatinine &gt;2.0 x ULN; total white blood cell count (WBC) &lt;2.5 x 10^9&#x2F;L; absolute neutrophil count &lt;1.5 x 10^9&#x2F;L; platelets &lt;100 x 10^9&#x2F;L.</p><ul><li>Unresolved or unstable serious adverse events from prior adjuvant chemotherapy or radiotherapy;</li><li>Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication.
Subjects with ulcerative colitis are also excluded;</li><li>Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test - urine or serum - within 7 days prior to randomisation);</li><li>Women of childbearing potential and male participants with partners of child bearing potential, including women whose last menstrual period was &lt;1 year ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment (adequate contraceptive measures: intra-uterine device, barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence.
Oral, injectable, or implant hormonal contraceptives are not indicated in this patient population);</li><li>Concomitant use of CYP3A4 inhibitors or inducers.</li></ul>
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 410 ops
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{
  "city": "Mendoza",
  "status": "NOT_YET_RECRUITING",
  "country": "Argentina",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": -32.88946,
    "lon": -68.84582
  }
}
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{
  "lat": -31.64881,
  "lon": -60.70868
}
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{
  "zip": "110-744",
  "city": "Youngun-dong - Seoul",
  "status": "NOT_YET_RECRUITING",
  "country": "Argentina",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
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{
  "lat": -37.75,
  "lon": 145.06667
}
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{
  "lat": 49.59438,
  "lon": 18.01028
}
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{
  "lat": 43.10322,
  "lon": 5.87816
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{
  "zip": "23843",
  "city": "Bad Oldesloe",
  "status": "RECRUITING",
  "country": "Germany",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 53.81167,
    "lon": 10.37417
  }
}
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  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
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[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
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{
  "zip": "40225",
  "city": "Düsseldorf",
  "status": "RECRUITING",
  "country": "Germany",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 51.22319,
    "lon": 6.77927
  }
}
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  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
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{
  "zip": "99085",
  "city": "Erfurt",
  "status": "RECRUITING",
  "country": "Germany",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 50.97734,
    "lon": 11.03536
  }
}
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{
  "zip": "30177",
  "city": "Hanover",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "G",
  "geoPoint": {
    "lat": 52.37052,
    "lon": 9.73322
  }
}
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{
  "lat": 49.40768,
  "lon": 8.69079
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{
  "zip": "24558",
  "city": "Henstedt-Ulzburg",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
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replace /protocolSection/contactsLocationsModule/locations/299/status
Triage: Uncategorized
Uncategorized Operation 65
Before
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After
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replace /protocolSection/contactsLocationsModule/locations/304/status
Triage: Uncategorized
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Before
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replace /protocolSection/contactsLocationsModule/locations/307/status
Triage: Uncategorized
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Before
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replace /protocolSection/contactsLocationsModule/locations/309/status
Triage: Uncategorized
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Before
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After
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add /protocolSection/contactsLocationsModule/locations/309/contacts
Triage: Uncategorized
Uncategorized Operation 69
After
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
add /protocolSection/contactsLocationsModule/locations/313
Triage: Uncategorized
Uncategorized Operation 70
After
{
  "zip": "68161",
  "city": "Mannheim",
  "status": "RECRUITING",
  "country": "Germany",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 49.4891,
    "lon": 8.46694
  }
}
add /protocolSection/contactsLocationsModule/locations/322
Triage: Uncategorized
Uncategorized Operation 71
After
{
  "zip": "81377",
  "city": "Muechen",
  "status": "ACTIVE_NOT_RECRUITING",
  "country": "Germany",
  "facility": "GSK Clinical Trials Call Centre"
}
add /protocolSection/contactsLocationsModule/locations/323
Triage: Uncategorized
Uncategorized Operation 72
After
{
  "zip": "99974",
  "city": "Muehljausen",
  "status": "RECRUITING",
  "country": "Germany",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
remove /protocolSection/contactsLocationsModule/locations/326
Triage: Uncategorized
Uncategorized Operation 73
Before
{
  "zip": "99974",
  "city": "Mühlhausen",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 51.20896,
    "lon": 10.45275
  }
}
replace /protocolSection/contactsLocationsModule/locations/331/status
Triage: Uncategorized
Uncategorized Operation 74
Before
NOT_YET_RECRUITING
After
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/332
Triage: Uncategorized
Uncategorized Operation 75
Before
{
  "zip": "81377",
  "city": "München",
  "status": "ACTIVE_NOT_RECRUITING",
  "country": "Germany",
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 51.60698,
    "lon": 13.31243
  }
}
replace /protocolSection/contactsLocationsModule/locations/336/status
Triage: Uncategorized
Uncategorized Operation 76
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/350/status
Triage: Uncategorized
Uncategorized Operation 77
Before
NOT_YET_RECRUITING
After
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/361
Triage: Uncategorized
Uncategorized Operation 78
Before
{
  "zip": "66113",
  "city": "Saarbrücken",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 49.23262,
    "lon": 7.00982
  }
}
replace /protocolSection/contactsLocationsModule/locations/362/status
Triage: Uncategorized
Uncategorized Operation 79
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/363/status
Triage: Uncategorized
Uncategorized Operation 80
Before
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After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/367/status
Triage: Uncategorized
Uncategorized Operation 81
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/376/status
Triage: Uncategorized
Uncategorized Operation 82
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/376/contacts
Triage: Uncategorized
Uncategorized Operation 83
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/382/status
Triage: Uncategorized
Uncategorized Operation 84
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/384/city
Triage: Uncategorized
Uncategorized Operation 85
Before
Villingen-Schwenningen
After
Villinfwn-Schwenningen
remove /protocolSection/contactsLocationsModule/locations/384/geoPoint
Triage: Uncategorized
Uncategorized Operation 86
Before
{
  "lat": 48.06226,
  "lon": 8.49358
}
replace /protocolSection/contactsLocationsModule/locations/385/status
Triage: Uncategorized
Uncategorized Operation 87
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/389/status
Triage: Uncategorized
Uncategorized Operation 88
Before
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After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/391/status
Triage: Uncategorized
Uncategorized Operation 89
Before
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After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/396/status
Triage: Uncategorized
Uncategorized Operation 90
Before
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After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/397/status
Triage: Uncategorized
Uncategorized Operation 91
Before
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After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/399/status
Triage: Uncategorized
Uncategorized Operation 92
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/400/status
Triage: Uncategorized
Uncategorized Operation 93
Before
NOT_YET_RECRUITING
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/400/contacts
Triage: Uncategorized
Uncategorized Operation 94
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/404/status
Triage: Uncategorized
Uncategorized Operation 95
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/405/status
Triage: Uncategorized
Uncategorized Operation 96
Before
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After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/406/status
Triage: Uncategorized
Uncategorized Operation 97
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/407
Triage: Uncategorized
Uncategorized Operation 98
After
{
  "zip": "18547",
  "city": "Neo Faliro",
  "status": "RECRUITING",
  "country": "Greece",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 37.9464,
    "lon": 23.66736
  }
}
replace /protocolSection/contactsLocationsModule/locations/409/status
Triage: Uncategorized
Uncategorized Operation 99
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/410/status
Triage: Uncategorized
Uncategorized Operation 100
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/412/status
Triage: Uncategorized
Uncategorized Operation 101
Before
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After
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replace /protocolSection/contactsLocationsModule/locations/413/status
Triage: Uncategorized
Uncategorized Operation 102
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/415/status
Triage: Uncategorized
Uncategorized Operation 103
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/415/contacts
Triage: Uncategorized
Uncategorized Operation 104
After
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/417/status
Triage: Uncategorized
Uncategorized Operation 105
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/419/status
Triage: Uncategorized
Uncategorized Operation 106
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/422/city
Triage: Uncategorized
Uncategorized Operation 107
Before
Hyderabaad
After
Hyderabad
add /protocolSection/contactsLocationsModule/locations/422/geoPoint
Triage: Uncategorized
Uncategorized Operation 108
After
{
  "lat": 17.38405,
  "lon": 78.45636
}
replace /protocolSection/contactsLocationsModule/locations/427/status
Triage: Uncategorized
Uncategorized Operation 109
Before
NOT_YET_RECRUITING
After
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add /protocolSection/contactsLocationsModule/locations/432
Triage: Uncategorized
Uncategorized Operation 110
After
{
  "zip": "00007",
  "city": "Dublin",
  "status": "RECRUITING",
  "country": "Ireland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 53.33306,
    "lon": -6.24889
  }
}
add /protocolSection/contactsLocationsModule/locations/433
Triage: Uncategorized
Uncategorized Operation 111
After
{
  "zip": "00008",
  "city": "Dublin",
  "status": "RECRUITING",
  "country": "Ireland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 53.33306,
    "lon": -6.24889
  }
}
add /protocolSection/contactsLocationsModule/locations/434
Triage: Uncategorized
Uncategorized Operation 112
After
{
  "zip": "0009",
  "city": "Dublin",
  "status": "RECRUITING",
  "country": "Ireland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 53.33306,
    "lon": -6.24889
  }
}
replace /protocolSection/contactsLocationsModule/locations/436/status
Triage: Uncategorized
Uncategorized Operation 113
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/437/status
Triage: Uncategorized
Uncategorized Operation 114
Before
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/438/status
Triage: Uncategorized
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Before
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replace /protocolSection/contactsLocationsModule/locations/439/status
Triage: Uncategorized
Uncategorized Operation 116
Before
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After
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add /protocolSection/contactsLocationsModule/locations/440
Triage: Uncategorized
Uncategorized Operation 117
After
{
  "zip": "00024",
  "city": "Tallaght, Dublin",
  "status": "RECRUITING",
  "country": "Ireland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
replace /protocolSection/contactsLocationsModule/locations/443/status
Triage: Uncategorized
Uncategorized Operation 118
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/443/city
Triage: Uncategorized
Uncategorized Operation 119
Before
Beersheba
After
Wilton,Cork
remove /protocolSection/contactsLocationsModule/locations/443/zip
Triage: Uncategorized
Uncategorized Operation 120
Before
84101
replace /protocolSection/contactsLocationsModule/locations/443/country
Triage: Uncategorized
Uncategorized Operation 121
Before
Israel
After
Ireland
replace /protocolSection/contactsLocationsModule/locations/443/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 122
Before
31.25181
After
51.89797
replace /protocolSection/contactsLocationsModule/locations/443/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 123
Before
34.7913
After
-8.47061
replace /protocolSection/contactsLocationsModule/locations/444/status
Triage: Uncategorized
Uncategorized Operation 124
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/444/city
Triage: Uncategorized
Uncategorized Operation 125
Before
Haifa
After
Beersheba
replace /protocolSection/contactsLocationsModule/locations/444/zip
Triage: Uncategorized
Uncategorized Operation 126
Before
31096
After
84101
replace /protocolSection/contactsLocationsModule/locations/444/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 127
Before
32.81303
After
31.25181
replace /protocolSection/contactsLocationsModule/locations/444/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 128
Before
34.99928
After
34.7913
replace /protocolSection/contactsLocationsModule/locations/445/facility
Triage: Uncategorized
Uncategorized Operation 129
Before
GSK Clinical Trials Call Center
After
GSK Clinical Trials Call Centre
replace /protocolSection/contactsLocationsModule/locations/445/status
Triage: Uncategorized
Uncategorized Operation 130
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/445/city
Triage: Uncategorized
Uncategorized Operation 131
Before
Holon
After
Haifa
replace /protocolSection/contactsLocationsModule/locations/445/zip
Triage: Uncategorized
Uncategorized Operation 132
Before
58100
After
31096
replace /protocolSection/contactsLocationsModule/locations/445/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 133
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32.01034
After
32.81303
replace /protocolSection/contactsLocationsModule/locations/445/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 134
Before
34.77918
After
34.99928
replace /protocolSection/contactsLocationsModule/locations/446/facility
Triage: Uncategorized
Uncategorized Operation 135
Before
GSK Clinical Trials Call Centre
After
GSK Clinical Trials Call Center
replace /protocolSection/contactsLocationsModule/locations/446/status
Triage: Uncategorized
Uncategorized Operation 136
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/446/city
Triage: Uncategorized
Uncategorized Operation 137
Before
Jerusalem
After
Holon
replace /protocolSection/contactsLocationsModule/locations/446/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 138
Before
31.76904
After
32.01034
replace /protocolSection/contactsLocationsModule/locations/446/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 139
Before
35.21633
After
34.77918
add /protocolSection/contactsLocationsModule/locations/446/zip
Triage: Uncategorized
Uncategorized Operation 140
After
58100
replace /protocolSection/contactsLocationsModule/locations/447/status
Triage: Uncategorized
Uncategorized Operation 141
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/447/city
Triage: Uncategorized
Uncategorized Operation 142
Before
Ramat Gan
After
Jerusalem
remove /protocolSection/contactsLocationsModule/locations/447/zip
Triage: Uncategorized
Uncategorized Operation 143
Before
52621
replace /protocolSection/contactsLocationsModule/locations/447/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 144
Before
32.08227
After
31.76904
replace /protocolSection/contactsLocationsModule/locations/447/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 145
Before
34.81065
After
35.21633
replace /protocolSection/contactsLocationsModule/locations/448/status
Triage: Uncategorized
Uncategorized Operation 146
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/448/city
Triage: Uncategorized
Uncategorized Operation 147
Before
Rehovot
After
Netanya
remove /protocolSection/contactsLocationsModule/locations/448/zip
Triage: Uncategorized
Uncategorized Operation 148
Before
76100
replace /protocolSection/contactsLocationsModule/locations/448/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 149
Before
31.89421
After
32.33291
replace /protocolSection/contactsLocationsModule/locations/448/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 150
Before
34.81199
After
34.85992
replace /protocolSection/contactsLocationsModule/locations/449/facility
Triage: Uncategorized
Uncategorized Operation 151
Before
GSK Clinical Trials Call Center
After
GSK Clinical Trials Call Centre
replace /protocolSection/contactsLocationsModule/locations/449/status
Triage: Uncategorized
Uncategorized Operation 152
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/449/city
Triage: Uncategorized
Uncategorized Operation 153
Before
Tel Aviv
After
Ramat Gan
replace /protocolSection/contactsLocationsModule/locations/449/zip
Triage: Uncategorized
Uncategorized Operation 154
Before
64239
After
52621
replace /protocolSection/contactsLocationsModule/locations/449/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 155
Before
32.08088
After
32.08227
replace /protocolSection/contactsLocationsModule/locations/449/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 156
Before
34.78057
After
34.81065
add /protocolSection/contactsLocationsModule/locations/450
Triage: Uncategorized
Uncategorized Operation 157
After
{
  "zip": "76100",
  "city": "Rehovot",
  "status": "RECRUITING",
  "country": "Israel",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 31.89421,
    "lon": 34.81199
  }
}
add /protocolSection/contactsLocationsModule/locations/451
Triage: Uncategorized
Uncategorized Operation 158
After
{
  "zip": "64239",
  "city": "Tel Aviv",
  "status": "RECRUITING",
  "country": "Israel",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 32.08088,
    "lon": 34.78057
  }
}
replace /protocolSection/contactsLocationsModule/locations/453/status
Triage: Uncategorized
Uncategorized Operation 159
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/455/status
Triage: Uncategorized
Uncategorized Operation 160
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/458/status
Triage: Uncategorized
Uncategorized Operation 161
Before
NOT_YET_RECRUITING
After
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add /protocolSection/contactsLocationsModule/locations/459
Triage: Uncategorized
Uncategorized Operation 162
After
{
  "zip": "40139",
  "city": "Bologna",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 44.49381,
    "lon": 11.33875
  }
}
replace /protocolSection/contactsLocationsModule/locations/463/status
Triage: Uncategorized
Uncategorized Operation 163
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/464/status
Triage: Uncategorized
Uncategorized Operation 164
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/468/status
Triage: Uncategorized
Uncategorized Operation 165
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/473
Triage: Uncategorized
Uncategorized Operation 166
After
{
  "zip": "16132",
  "city": "Genova",
  "status": "ACTIVE_NOT_RECRUITING",
  "country": "Italy",
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 45.21604,
    "lon": 11.87211
  }
}
add /protocolSection/contactsLocationsModule/locations/475
Triage: Uncategorized
Uncategorized Operation 167
After
{
  "zip": "16132",
  "city": "Genova",
  "status": "RECRUITING",
  "country": "Italy",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 45.21604,
    "lon": 11.87211
  }
}
add /protocolSection/contactsLocationsModule/locations/476
Triage: Uncategorized
Uncategorized Operation 168
After
{
  "zip": "73100",
  "city": "Lecce",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 40.35481,
    "lon": 18.17244
  }
}
replace /protocolSection/contactsLocationsModule/locations/478/status
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add /protocolSection/contactsLocationsModule/locations/482
Triage: Uncategorized
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After
{
  "zip": "47014",
  "city": "Meldola (FC)",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 44.12775,
    "lon": 12.0626
  }
}
replace /protocolSection/contactsLocationsModule/locations/484/facility
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GSK Clinical Trials Call Centre
replace /protocolSection/contactsLocationsModule/locations/484/zip
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20141
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20052
add /protocolSection/contactsLocationsModule/locations/485
Triage: Uncategorized
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After
{
  "zip": "20141",
  "city": "Milan",
  "status": "RECRUITING",
  "country": "Italy",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 42.78235,
    "lon": 12.59836
  }
}
add /protocolSection/contactsLocationsModule/locations/486
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After
{
  "zip": "20142",
  "city": "Milan",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 42.78235,
    "lon": 12.59836
  }
}
replace /protocolSection/contactsLocationsModule/locations/490/city
Triage: Uncategorized
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Padru
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Montepulciano (Sie)
replace /protocolSection/contactsLocationsModule/locations/490/zip
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90146
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53045
replace /protocolSection/contactsLocationsModule/locations/490/geoPoint/lat
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40.76619
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43.09998
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9.521
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11.78704
replace /protocolSection/contactsLocationsModule/locations/492/city
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Pavia
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Patra
replace /protocolSection/contactsLocationsModule/locations/492/zip
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27100
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90146
remove /protocolSection/contactsLocationsModule/locations/492/geoPoint
Triage: Uncategorized
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Before
{
  "lat": 45.19205,
  "lon": 9.15917
}
replace /protocolSection/contactsLocationsModule/locations/493/facility
Triage: Uncategorized
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Before
GSK Clinical Trials Call Center
After
GSK Clinical Trials Call Centre
replace /protocolSection/contactsLocationsModule/locations/493/status
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NOT_YET_RECRUITING
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/493/city
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Perugia
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Pavia
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06156
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27100
replace /protocolSection/contactsLocationsModule/locations/493/geoPoint/lat
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43.1122
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replace /protocolSection/contactsLocationsModule/locations/493/geoPoint/lon
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12.38878
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9.15917
replace /protocolSection/contactsLocationsModule/locations/494/facility
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GSK Clinical Trials Call Centre
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GSK Clinical Trials Call Center
replace /protocolSection/contactsLocationsModule/locations/494/status
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NOT_YET_RECRUITING
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ACTIVE_NOT_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/494/city
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Piacenza
After
Perugia
replace /protocolSection/contactsLocationsModule/locations/494/zip
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29100
After
06156
remove /protocolSection/contactsLocationsModule/locations/494/contacts
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Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/494/geoPoint/lat
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43.1122
replace /protocolSection/contactsLocationsModule/locations/494/geoPoint/lon
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9.69342
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12.38878
add /protocolSection/contactsLocationsModule/locations/495
Triage: Uncategorized
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After
{
  "zip": "29100",
  "city": "Piacenza",
  "status": "ACTIVE_NOT_RECRUITING",
  "country": "Italy",
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 45.05242,
    "lon": 9.69342
  }
}
add /protocolSection/contactsLocationsModule/locations/497
Triage: Uncategorized
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After
{
  "zip": "53036",
  "city": "Poggibonsi (Siena)",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 43.47064,
    "lon": 11.14804
  }
}
replace /protocolSection/contactsLocationsModule/locations/502/status
Triage: Uncategorized
Uncategorized Operation 199
Before
NOT_YET_RECRUITING
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/502/contacts
Triage: Uncategorized
Uncategorized Operation 200
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/503/status
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NOT_YET_RECRUITING
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/506/status
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replace /protocolSection/contactsLocationsModule/locations/509/status
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/509/contacts
Triage: Uncategorized
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Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/514/status
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replace /protocolSection/contactsLocationsModule/locations/534/status
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NOT_YET_RECRUITING
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TERMINATED
remove /protocolSection/contactsLocationsModule/locations/534/contacts
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Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/535/status
Triage: Uncategorized
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RECRUITING
After
TERMINATED
remove /protocolSection/contactsLocationsModule/locations/535/contacts
Triage: Uncategorized
Uncategorized Operation 210
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/536/status
Triage: Uncategorized
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NOT_YET_RECRUITING
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TERMINATED
remove /protocolSection/contactsLocationsModule/locations/536/contacts
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Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
add /protocolSection/contactsLocationsModule/locations/538
Triage: Uncategorized
Uncategorized Operation 213
After
{
  "zip": "6720",
  "city": "Mexic0 DF",
  "status": "NOT_YET_RECRUITING",
  "country": "Mexico",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
remove /protocolSection/contactsLocationsModule/locations/541
Triage: Uncategorized
Uncategorized Operation 214
Before
{
  "zip": "6720",
  "city": "Mexico City",
  "status": "NOT_YET_RECRUITING",
  "country": "Mexico",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 19.42847,
    "lon": -99.12766
  }
}
add /protocolSection/contactsLocationsModule/locations/544
Triage: Uncategorized
Uncategorized Operation 215
After
{
  "zip": "3818 ES",
  "city": "Amersfoort",
  "status": "NOT_YET_RECRUITING",
  "country": "Netherlands",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 52.155,
    "lon": 5.3875
  }
}
replace /protocolSection/contactsLocationsModule/locations/547/status
Triage: Uncategorized
Uncategorized Operation 216
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NOT_YET_RECRUITING
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/547/contacts
Triage: Uncategorized
Uncategorized Operation 217
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/549/status
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replace /protocolSection/contactsLocationsModule/locations/550/status
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replace /protocolSection/contactsLocationsModule/locations/551/status
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/551/contacts
Triage: Uncategorized
Uncategorized Operation 221
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/554/status
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remove /protocolSection/contactsLocationsModule/locations/554/contacts
Triage: Uncategorized
Uncategorized Operation 223
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/556/status
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/557/status
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replace /protocolSection/contactsLocationsModule/locations/558/status
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/558/contacts
Triage: Uncategorized
Uncategorized Operation 227
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/559/status
Triage: Uncategorized
Uncategorized Operation 228
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/559/contacts
Triage: Uncategorized
Uncategorized Operation 229
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/560/status
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Uncategorized Operation 230
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/561/status
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replace /protocolSection/contactsLocationsModule/locations/562/status
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replace /protocolSection/contactsLocationsModule/locations/563/status
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replace /protocolSection/contactsLocationsModule/locations/564/status
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replace /protocolSection/contactsLocationsModule/locations/565/status
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/566/status
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/566/contacts
Triage: Uncategorized
Uncategorized Operation 237
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/567/status
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Uncategorized Operation 238
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replace /protocolSection/contactsLocationsModule/locations/568/status
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Uncategorized Operation 239
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replace /protocolSection/contactsLocationsModule/locations/574/status
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replace /protocolSection/contactsLocationsModule/locations/575/status
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replace /protocolSection/contactsLocationsModule/locations/576/status
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replace /protocolSection/contactsLocationsModule/locations/577/status
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replace /protocolSection/contactsLocationsModule/locations/582/status
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replace /protocolSection/contactsLocationsModule/locations/583/status
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replace /protocolSection/contactsLocationsModule/locations/584/status
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replace /protocolSection/contactsLocationsModule/locations/585/status
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replace /protocolSection/contactsLocationsModule/locations/592/status
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After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/592/contacts
Triage: Uncategorized
Uncategorized Operation 249
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/593/status
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replace /protocolSection/contactsLocationsModule/locations/594/status
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replace /protocolSection/contactsLocationsModule/locations/595/status
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replace /protocolSection/contactsLocationsModule/locations/597/status
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replace /protocolSection/contactsLocationsModule/locations/598/status
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replace /protocolSection/contactsLocationsModule/locations/599/city
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Uncategorized Operation 255
Before
Rzeszów
After
Opole
replace /protocolSection/contactsLocationsModule/locations/599/zip
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Uncategorized Operation 256
Before
35-055
After
45-060
replace /protocolSection/contactsLocationsModule/locations/599/geoPoint/lat
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Uncategorized Operation 257
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50.04132
After
50.67119
replace /protocolSection/contactsLocationsModule/locations/599/geoPoint/lon
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21.99901
After
17.92604
add /protocolSection/contactsLocationsModule/locations/600
Triage: Uncategorized
Uncategorized Operation 259
After
{
  "zip": "35-055",
  "city": "Rzeszów",
  "status": "RECRUITING",
  "country": "Poland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 50.04132,
    "lon": 21.99901
  }
}
replace /protocolSection/contactsLocationsModule/locations/603/status
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replace /protocolSection/contactsLocationsModule/locations/609/status
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add /protocolSection/contactsLocationsModule/locations/610
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Uncategorized Operation 262
After
{
  "zip": "022328",
  "city": "Bucharest",
  "status": "RECRUITING",
  "country": "Romania",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 44.43225,
    "lon": 26.10626
  }
}
replace /protocolSection/contactsLocationsModule/locations/612/status
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replace /protocolSection/contactsLocationsModule/locations/613/status
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add /protocolSection/contactsLocationsModule/locations/614
Triage: Uncategorized
Uncategorized Operation 265
After
{
  "zip": "400015",
  "city": "Cluj-Napoca",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 46.76667,
    "lon": 23.6
  }
}
replace /protocolSection/contactsLocationsModule/locations/616/status
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replace /protocolSection/contactsLocationsModule/locations/617/status
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replace /protocolSection/contactsLocationsModule/locations/618/status
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replace /protocolSection/contactsLocationsModule/locations/619/status
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replace /protocolSection/contactsLocationsModule/locations/622/status
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replace /protocolSection/contactsLocationsModule/locations/623/status
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replace /protocolSection/contactsLocationsModule/locations/628/status
Triage: Uncategorized
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replace /protocolSection/contactsLocationsModule/locations/629/status
Triage: Uncategorized
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replace /protocolSection/contactsLocationsModule/locations/630/status
Triage: Uncategorized
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/630/contacts
Triage: Uncategorized
Uncategorized Operation 279
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/631/status
Triage: Uncategorized
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Triage: Uncategorized
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replace /protocolSection/contactsLocationsModule/locations/633/status
Triage: Uncategorized
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replace /protocolSection/contactsLocationsModule/locations/634/status
Triage: Uncategorized
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replace /protocolSection/contactsLocationsModule/locations/634/city
Triage: Uncategorized
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Before
Voronezh
After
Samara
replace /protocolSection/contactsLocationsModule/locations/634/zip
Triage: Uncategorized
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394062
After
443066
replace /protocolSection/contactsLocationsModule/locations/634/geoPoint/lat
Triage: Uncategorized
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51.66833
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53.20767
replace /protocolSection/contactsLocationsModule/locations/634/geoPoint/lon
Triage: Uncategorized
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Before
39.19204
After
50.13553
add /protocolSection/contactsLocationsModule/locations/635
Triage: Uncategorized
Uncategorized Operation 288
After
{
  "zip": "394062",
  "city": "Voronezh",
  "status": "RECRUITING",
  "country": "Russia",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 51.66833,
    "lon": 39.19204
  }
}
replace /protocolSection/contactsLocationsModule/locations/637/status
Triage: Uncategorized
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replace /protocolSection/contactsLocationsModule/locations/639/status
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/639/city
Triage: Uncategorized
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Before
Poprad
After
Košice
replace /protocolSection/contactsLocationsModule/locations/639/zip
Triage: Uncategorized
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05801
After
04190
replace /protocolSection/contactsLocationsModule/locations/639/geoPoint/lat
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49.06144
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48.71441
replace /protocolSection/contactsLocationsModule/locations/639/geoPoint/lon
Triage: Uncategorized
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Before
20.29798
After
21.25802
add /protocolSection/contactsLocationsModule/locations/640
Triage: Uncategorized
Uncategorized Operation 296
After
{
  "zip": "05801",
  "city": "Poprad",
  "status": "RECRUITING",
  "country": "Slovakia",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 49.06144,
    "lon": 20.29798
  }
}
replace /protocolSection/contactsLocationsModule/locations/643/status
Triage: Uncategorized
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Before
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After
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add /protocolSection/contactsLocationsModule/locations/645
Triage: Uncategorized
Uncategorized Operation 298
After
{
  "zip": "1",
  "city": "Groenkloof",
  "status": "NOT_YET_RECRUITING",
  "country": "South Africa",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": -31.78089,
    "lon": 25.50906
  }
}
replace /protocolSection/contactsLocationsModule/locations/647/city
Triage: Uncategorized
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Observatory
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Panorama
replace /protocolSection/contactsLocationsModule/locations/647/zip
Triage: Uncategorized
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Before
7925
After
7500
replace /protocolSection/contactsLocationsModule/locations/647/geoPoint/lat
Triage: Uncategorized
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Before
-33.93613
After
-28.75383
replace /protocolSection/contactsLocationsModule/locations/647/geoPoint/lon
Triage: Uncategorized
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Before
18.46787
After
31.89113
add /protocolSection/contactsLocationsModule/locations/648
Triage: Uncategorized
Uncategorized Operation 303
After
{
  "zip": "2193",
  "city": "Parktown",
  "status": "RECRUITING",
  "country": "South Africa",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": -26.18205,
    "lon": 28.02671
  }
}
add /protocolSection/contactsLocationsModule/locations/650
Triage: Uncategorized
Uncategorized Operation 304
After
{
  "zip": "181",
  "city": "Pretoria",
  "status": "RECRUITING",
  "country": "South Africa",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": -25.74486,
    "lon": 28.18783
  }
}
add /protocolSection/contactsLocationsModule/locations/651
Triage: Uncategorized
Uncategorized Operation 305
After
{
  "zip": "41",
  "city": "Pretoria",
  "status": "NOT_YET_RECRUITING",
  "country": "South Africa",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": -25.74486,
    "lon": 28.18783
  }
}
add /protocolSection/contactsLocationsModule/locations/652
Triage: Uncategorized
Uncategorized Operation 306
After
{
  "zip": "2199",
  "city": "Sandton",
  "status": "RECRUITING",
  "country": "South Africa",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": -26.104,
    "lon": 28.054
  }
}
add /protocolSection/contactsLocationsModule/locations/653
Triage: Uncategorized
Uncategorized Operation 307
After
{
  "zip": "7505",
  "city": "Tygerberg",
  "status": "NOT_YET_RECRUITING",
  "country": "South Africa",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
replace /protocolSection/contactsLocationsModule/locations/656/status
Triage: Uncategorized
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replace /protocolSection/contactsLocationsModule/locations/657/status
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Before
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/657/city
Triage: Uncategorized
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Before
P’ungnabi-dong
After
Pungnap-dong
remove /protocolSection/contactsLocationsModule/locations/657/geoPoint
Triage: Uncategorized
Uncategorized Operation 311
Before
{
  "lat": 37.53023,
  "lon": 127.11008
}
replace /protocolSection/contactsLocationsModule/locations/659/status
Triage: Uncategorized
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Before
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replace /protocolSection/contactsLocationsModule/locations/661/city
Triage: Uncategorized
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Before
Alcoy/Alicante
After
Youngun-dong - Seoul
replace /protocolSection/contactsLocationsModule/locations/661/zip
Triage: Uncategorized
Uncategorized Operation 314
Before
03804
After
110-744
replace /protocolSection/contactsLocationsModule/locations/661/country
Triage: Uncategorized
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Before
Spain
After
South Korea
add /protocolSection/contactsLocationsModule/locations/662
Triage: Uncategorized
Uncategorized Operation 316
After
{
  "zip": "03804",
  "city": "Alcoy/Alicante",
  "status": "RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
replace /protocolSection/contactsLocationsModule/locations/664/status
Triage: Uncategorized
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Before
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/666/status
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Before
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replace /protocolSection/contactsLocationsModule/locations/672/status
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replace /protocolSection/contactsLocationsModule/locations/675/status
Triage: Uncategorized
Uncategorized Operation 321
Before
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/675/contacts
Triage: Uncategorized
Uncategorized Operation 322
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/676/status
Triage: Uncategorized
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Before
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NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/678/status
Triage: Uncategorized
Uncategorized Operation 324
Before
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/678/contacts
Triage: Uncategorized
Uncategorized Operation 325
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/680/status
Triage: Uncategorized
Uncategorized Operation 326
Before
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ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/680/contacts
Triage: Uncategorized
Uncategorized Operation 327
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/682/status
Triage: Uncategorized
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Before
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RECRUITING
replace /protocolSection/contactsLocationsModule/locations/683/status
Triage: Uncategorized
Uncategorized Operation 329
Before
TERMINATED
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/683/contacts
Triage: Uncategorized
Uncategorized Operation 330
After
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/685/status
Triage: Uncategorized
Uncategorized Operation 331
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replace /protocolSection/contactsLocationsModule/locations/687/status
Triage: Uncategorized
Uncategorized Operation 332
Before
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add /protocolSection/contactsLocationsModule/locations/690
Triage: Uncategorized
Uncategorized Operation 333
After
{
  "zip": "08034",
  "city": "Mataró",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 41.54211,
    "lon": 2.4445
  }
}
replace /protocolSection/contactsLocationsModule/locations/692/status
Triage: Uncategorized
Uncategorized Operation 334
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/695
Triage: Uncategorized
Uncategorized Operation 335
After
{
  "zip": "30008",
  "city": "Murcia",
  "status": "RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 37.98704,
    "lon": -1.13004
  }
}
replace /protocolSection/contactsLocationsModule/locations/701/status
Triage: Uncategorized
Uncategorized Operation 336
Before
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After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/703/status
Triage: Uncategorized
Uncategorized Operation 337
Before
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After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/704/status
Triage: Uncategorized
Uncategorized Operation 338
Before
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After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/705
Triage: Uncategorized
Uncategorized Operation 339
After
{
  "zip": "41071",
  "city": "Seville",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 37.38283,
    "lon": -5.97317
  }
}
replace /protocolSection/contactsLocationsModule/locations/707/facility
Triage: Uncategorized
Uncategorized Operation 340
Before
GSK Clinical Trials Call Centre
After
GSK Clinical Trials Call Center
replace /protocolSection/contactsLocationsModule/locations/707/status
Triage: Uncategorized
Uncategorized Operation 341
Before
NOT_YET_RECRUITING
After
ACTIVE_NOT_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/707/city
Triage: Uncategorized
Uncategorized Operation 342
Before
Seville
After
Solna
replace /protocolSection/contactsLocationsModule/locations/707/zip
Triage: Uncategorized
Uncategorized Operation 343
Before
41071
After
Se-171 76
remove /protocolSection/contactsLocationsModule/locations/707/contacts
Triage: Uncategorized
Uncategorized Operation 344
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
remove /protocolSection/contactsLocationsModule/locations/707/geoPoint
Triage: Uncategorized
Uncategorized Operation 345
Before
{
  "lat": 37.38283,
  "lon": -5.97317
}
remove /protocolSection/contactsLocationsModule/locations/708
Triage: Uncategorized
Uncategorized Operation 346
Before
{
  "zip": "Se-171 76",
  "city": "Solana",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 39.47969,
    "lon": -5.47845
  }
}
replace /protocolSection/contactsLocationsModule/locations/715/status
Triage: Uncategorized
Uncategorized Operation 347
Before
NOT_YET_RECRUITING
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/715/contacts
Triage: Uncategorized
Uncategorized Operation 348
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/716/status
Triage: Uncategorized
Uncategorized Operation 349
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/717/status
Triage: Uncategorized
Uncategorized Operation 350
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/719/status
Triage: Uncategorized
Uncategorized Operation 351
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/719/city
Triage: Uncategorized
Uncategorized Operation 352
Before
Chur
After
Bern
replace /protocolSection/contactsLocationsModule/locations/719/zip
Triage: Uncategorized
Uncategorized Operation 353
Before
7000
After
3010
replace /protocolSection/contactsLocationsModule/locations/719/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 354
Before
46.84986
After
46.94809
replace /protocolSection/contactsLocationsModule/locations/719/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 355
Before
9.53287
After
7.44744
add /protocolSection/contactsLocationsModule/locations/720
Triage: Uncategorized
Uncategorized Operation 356
After
{
  "zip": "7000",
  "city": "Chur",
  "status": "RECRUITING",
  "country": "Switzerland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 46.84986,
    "lon": 9.53287
  }
}
add /protocolSection/contactsLocationsModule/locations/721
Triage: Uncategorized
Uncategorized Operation 357
After
{
  "zip": "1272",
  "city": "Genolier",
  "status": "NOT_YET_RECRUITING",
  "country": "Switzerland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 46.43537,
    "lon": 6.21809
  }
}
replace /protocolSection/contactsLocationsModule/locations/723/status
Triage: Uncategorized
Uncategorized Operation 358
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/724/status
Triage: Uncategorized
Uncategorized Operation 359
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/726
Triage: Uncategorized
Uncategorized Operation 360
After
{
  "zip": "9007",
  "city": "Sankt Gallen",
  "status": "RECRUITING",
  "country": "Switzerland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "G",
  "geoPoint": {
    "lat": 47.42391,
    "lon": 9.37477
  }
}
replace /protocolSection/contactsLocationsModule/locations/729/status
Triage: Uncategorized
Uncategorized Operation 361
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/731/facility
Triage: Uncategorized
Uncategorized Operation 362
Before
GSK Clinical Trials Call Centre
After
G
replace /protocolSection/contactsLocationsModule/locations/731/status
Triage: Uncategorized
Uncategorized Operation 363
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/731/zip
Triage: Uncategorized
Uncategorized Operation 364
Before
8091
After
8008
add /protocolSection/contactsLocationsModule/locations/732
Triage: Uncategorized
Uncategorized Operation 365
After
{
  "zip": "8091",
  "city": "Zurich",
  "status": "RECRUITING",
  "country": "Switzerland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 47.36667,
    "lon": 8.55
  }
}
remove /protocolSection/contactsLocationsModule/locations/734
Triage: Uncategorized
Uncategorized Operation 366
Before
{
  "city": "Kaohsiung City",
  "status": "NOT_YET_RECRUITING",
  "country": "Taiwan",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 22.61626,
    "lon": 120.31333
  }
}
replace /protocolSection/contactsLocationsModule/locations/741/status
Triage: Uncategorized
Uncategorized Operation 367
Before
NOT_YET_RECRUITING
After
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/742
Triage: Uncategorized
Uncategorized Operation 368
Before
{
  "zip": "10400",
  "city": "Bangkok",
  "status": "NOT_YET_RECRUITING",
  "country": "Thailand",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 13.75398,
    "lon": 100.50144
  }
}
replace /protocolSection/contactsLocationsModule/locations/743/zip
Triage: Uncategorized
Uncategorized Operation 369
Before
10500
After
10700
replace /protocolSection/contactsLocationsModule/locations/745/status
Triage: Uncategorized
Uncategorized Operation 370
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/747/city
Triage: Uncategorized
Uncategorized Operation 371
Before
Prannok
After
Chernivtsi
replace /protocolSection/contactsLocationsModule/locations/747/zip
Triage: Uncategorized
Uncategorized Operation 372
Before
10700
After
58013
replace /protocolSection/contactsLocationsModule/locations/747/country
Triage: Uncategorized
Uncategorized Operation 373
Before
Thailand
After
Ukraine
add /protocolSection/contactsLocationsModule/locations/747/geoPoint
Triage: Uncategorized
Uncategorized Operation 374
After
{
  "lat": 48.29045,
  "lon": 25.93241
}
remove /protocolSection/contactsLocationsModule/locations/748
Triage: Uncategorized
Uncategorized Operation 375
Before
{
  "zip": "58013",
  "city": "Chernivtsy",
  "status": "NOT_YET_RECRUITING",
  "country": "Ukraine",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
add /protocolSection/contactsLocationsModule/locations/752
Triage: Uncategorized
Uncategorized Operation 376
After
{
  "zip": "79031",
  "city": "Lviv",
  "status": "NOT_YET_RECRUITING",
  "country": "Ukraine",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 49.83826,
    "lon": 24.02324
  }
}
replace /protocolSection/contactsLocationsModule/locations/756/status
Triage: Uncategorized
Uncategorized Operation 377
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/757/status
Triage: Uncategorized
Uncategorized Operation 378
Before
NOT_YET_RECRUITING
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/757/contacts
Triage: Uncategorized
Uncategorized Operation 379
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/760/status
Triage: Uncategorized
Uncategorized Operation 380
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/765/status
Triage: Uncategorized
Uncategorized Operation 381
Before
NOT_YET_RECRUITING
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/765/contacts
Triage: Uncategorized
Uncategorized Operation 382
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/768/status
Triage: Uncategorized
Uncategorized Operation 383
Before
NOT_YET_RECRUITING
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/768/contacts
Triage: Uncategorized
Uncategorized Operation 384
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
add /protocolSection/contactsLocationsModule/locations/769
Triage: Uncategorized
Uncategorized Operation 385
After
{
  "zip": "EX2 5DW",
  "city": "Exeter",
  "status": "NOT_YET_RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 50.7236,
    "lon": -3.52751
  }
}
replace /protocolSection/contactsLocationsModule/locations/771/status
Triage: Uncategorized
Uncategorized Operation 386
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/773/status
Triage: Uncategorized
Uncategorized Operation 387
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/773/contacts
Triage: Uncategorized
Uncategorized Operation 388
After
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/775/status
Triage: Uncategorized
Uncategorized Operation 389
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/777/status
Triage: Uncategorized
Uncategorized Operation 390
Before
NOT_YET_RECRUITING
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/777/contacts
Triage: Uncategorized
Uncategorized Operation 391
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/778/city
Triage: Uncategorized
Uncategorized Operation 392
Before
Leeds
After
Lancaster
replace /protocolSection/contactsLocationsModule/locations/778/zip
Triage: Uncategorized
Uncategorized Operation 393
Before
LS16 6QB
After
LA1 4RP
replace /protocolSection/contactsLocationsModule/locations/778/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 394
Before
53.79648
After
54.04649
replace /protocolSection/contactsLocationsModule/locations/778/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 395
Before
-1.54785
After
-2.79988
add /protocolSection/contactsLocationsModule/locations/779
Triage: Uncategorized
Uncategorized Operation 396
After
{
  "zip": "LS16 6QB",
  "city": "Leeds",
  "status": "ACTIVE_NOT_RECRUITING",
  "country": "United Kingdom",
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 53.79648,
    "lon": -1.54785
  }
}
replace /protocolSection/contactsLocationsModule/locations/781/status
Triage: Uncategorized
Uncategorized Operation 397
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/782/status
Triage: Uncategorized
Uncategorized Operation 398
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/784/status
Triage: Uncategorized
Uncategorized Operation 399
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/790
Triage: Uncategorized
Uncategorized Operation 400
After
{
  "zip": "W6 8RF",
  "city": "London",
  "status": "NOT_YET_RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 51.50853,
    "lon": -0.12574
  }
}
add /protocolSection/contactsLocationsModule/locations/791
Triage: Uncategorized
Uncategorized Operation 401
After
{
  "zip": "WC1E 6DB",
  "city": "London",
  "status": "NOT_YET_RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 51.50853,
    "lon": -0.12574
  }
}
replace /protocolSection/contactsLocationsModule/locations/796/city
Triage: Uncategorized
Uncategorized Operation 402
Before
Northwood
After
Newcastle upon Tyne
replace /protocolSection/contactsLocationsModule/locations/796/zip
Triage: Uncategorized
Uncategorized Operation 403
Before
HA6 2RN
After
NE4 6BE
replace /protocolSection/contactsLocationsModule/locations/796/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 404
Before
51.61162
After
54.97328
replace /protocolSection/contactsLocationsModule/locations/796/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 405
Before
-0.42454
After
-1.61396
add /protocolSection/contactsLocationsModule/locations/797
Triage: Uncategorized
Uncategorized Operation 406
After
{
  "zip": "HA6 2RN",
  "city": "Northwood",
  "status": "RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 51.61162,
    "lon": -0.42454
  }
}
replace /protocolSection/contactsLocationsModule/locations/800/status
Triage: Uncategorized
Uncategorized Operation 407
Before
NOT_YET_RECRUITING
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/800/contacts
Triage: Uncategorized
Uncategorized Operation 408
Before
[
  {
    "name": "GSK Clinical Trials Call Centre",
    "role": "CONTACT",
    "phone": "1 877 379 3718"
  }
]
replace /protocolSection/contactsLocationsModule/locations/804/status
Triage: Uncategorized
Uncategorized Operation 409
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/804/city
Triage: Uncategorized
Uncategorized Operation 410
Before
Preston
After
Prescott
replace /protocolSection/contactsLocationsModule/locations/804/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 411
Before
53.76282
After
52.7859
replace /protocolSection/contactsLocationsModule/locations/804/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 412
Before
-2.70452
After
-2.85287
replace /protocolSection/contactsLocationsModule/locations/805/status
Triage: Uncategorized
Uncategorized Operation 413
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/806/status
Triage: Uncategorized
Uncategorized Operation 414
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/807/city
Triage: Uncategorized
Uncategorized Operation 415
Before
Romford
After
Romfprd
remove /protocolSection/contactsLocationsModule/locations/807/geoPoint
Triage: Uncategorized
Uncategorized Operation 416
Before
{
  "lat": 51.57515,
  "lon": 0.18582
}
add /protocolSection/contactsLocationsModule/locations/813
Triage: Uncategorized
Uncategorized Operation 417
After
{
  "zip": "BN11 2DH",
  "city": "Worthing",
  "status": "RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 50.81795,
    "lon": -0.37538
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2008-02-12
After
2008-02-20
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2008-02-13
After
2008-02-29
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 4 ops
replace /protocolSection/identificationModule/secondaryIdInfos/0/id
Triage: Uncategorized
Uncategorized Operation 1
Before
BIG 2-06&#x2F;N063D
After
BIG 2-06&#x2F;N063D&#x2F;MAC13
add /protocolSection/sponsorCollaboratorsModule/collaborators/0
Triage: Uncategorized
Uncategorized Operation 4
After
{
  "name": "Breast International Group",
  "class": "OTHER"
}
add /protocolSection/sponsorCollaboratorsModule/collaborators/2
Triage: Uncategorized
Uncategorized Operation 5
After
{
  "name": "National Cancer Institute (NCI)",
  "class": "NIH"
}
add /protocolSection/sponsorCollaboratorsModule/collaborators/3
Triage: Uncategorized
Uncategorized Operation 6
After
{
  "name": "Canadian Cancer Trials Group",
  "class": "NETWORK"
}
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/0/id",
    "value": "BIG 2-06&#x2F;N063D&#x2F;MAC13"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2008-02-20"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2008-02-29"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/collaborators/0",
    "value": {
      "name": "Breast International Group",
      "class": "OTHER"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/collaborators/2",
    "value": {
      "name": "National Cancer Institute (NCI)",
      "class": "NIH"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/collaborators/3",
    "value": {
      "name": "Canadian Cancer Trials Group",
      "class": "NETWORK"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>INCLUSION CRITERIA:</p><ul><li>Age ≥ 18 years</li><li>Eastern Cooperative Oncology Group (ECOG) performance status ≥1;</li><li><p>Non-metastatic operable primary invasive adenocarcinoma of the breast fulfilling the following:</p><ol><li>Histologically confirmed;</li><li>Adequately excised (exceptions: patients who have &#x27;non-resectable&#x27; deep margin invasion are eligible provided they have had or will receive radiotherapy encompassing the region concerned; patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumour bed);</li><li>Axilla dissected; sentinel node sampling is allowed provided that axillary dissection follows confirmation of a positive sentinel node; sentinel node sampling alone is NOT acceptable after neoadjuvant chemotherapy (in patients receiving neoadjuvant chemotherapy lymph node status will be considered unknown, regardless of the results of post-chemotherapy axillary dissection);</li><li>Axillary node positive patient OR node negative patient with a tumour greater than or equal to 1.0 cm in greatest diameter (≥ T1c) according to TNM.</li></ol></li><li>Known hormone receptor status (ER&#x2F;PgR or ER alone);</li><li>Must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen.</li></ul><p>For design 1: Randomisation must be performed no longer than 12 weeks from day 1 of the last chemotherapy cycle after obtaining a post-chemotherapy LVEF ≥ 50.\nStudy treatment should start no more than 14 days after randomisation.</p><p>For design 2: Randomisation must be performed no longer than 6 weeks from day 1 of the last anthracycline-containing chemotherapy cycle after obtaining a post-anthracycline chemotherapy LVEF ≥ 50.\nStudy treatment should start no more than 14 days after randomization and must be concurrent with paclitaxel.</p><ul><li>Baseline LVEF ≥50% measured by echocardiography or MUGA scan after completion of all anthracycline-based (neo-) adjuvant chemotherapy and prior to the targeted therapy(ies).</li><li>Over expression and&#x2F;or amplification of HER2 in the invasive component of the primary tumour (in case of neoadjuvant treatment, tissue sample used for HER2 testing should be collected before neoadjuvant treatment starts), according to one of the following definitions [Wolff et al 2007] and confirmed by central laboratory prior to randomisation:</li><li>3+ over expression by IHC (&gt; 30% of invasive tumour cells);</li><li>2+ or 3+ (in 30% or less neoplastic cells) over expression by IHC AND in situ hybridization (FISH&#x2F;CISH) test demonstrating HER2 gene amplification;</li><li>HER2 gene amplification by FISH&#x2F;CISH ( &gt; 6 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of &gt; than 2.2.) Patients with a negative or equivocal overall result (FISH test ratio of &lt; 2.2, &lt; 6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.</li></ul><p>Equivocal local results may be submitted for a final determination by the central laboratory.</p><ul><li>Completion of all necessary baseline laboratory and radiological investigations</li><li>Signed written informed consent (approved by an Independent Ethics Committee (IEC) and obtained prior to any study specific screening procedures).</li></ul><p>EXCLUSION CRITERIA:</p><ul><li>History of any prior (ipsi- and&#x2F;or contralateral) invasive breast carcinoma;</li><li>Past or current history of malignant neoplasms, except for curatively treated: - Basal and squamous cell carcinoma of the skin;- Carcinoma in situ of the cervix</li><li>Any clinically staged T4 tumour, including inflammatory breast cancer;</li><li>Bilateral tumours;</li><li>Multifocal tumours;</li><li>Maximum cumulative dose of doxorubicin &gt;360mg&#x2F;m² or maximum cumulative dose of epirubicin &gt;720mg&#x2F;m² or any prior anthracyclines unrelated to the present breast cancer;</li><li>(Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support;</li><li>Any prior mediastinal irradiation except internal mammary node irradiation for the present breast cancer;</li><li>Patients with positive or suspicious internal mammary nodes identified by sentinel node technique which have not been irradiated or will not be irradiated, or patients with supraclavicular lymph node involvement (confirmed by fine needle aspirate or biopsy);</li><li>Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for breast cancer;</li><li>Concurrent anti-cancer treatment, except hormonal therapy;</li><li>Concurrent anti-cancer treatment in another investigational trial with hormone therapy or immunotherapy:</li><li>Serious cardiac illness or medical conditions including but not confined to:</li></ul><p>History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF &lt;50%); High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled); Angina pectoris requiring antianginal medication; Clinically significant valvular heart disease; Evidence of transmural infarction on ECG; Poorly controlled hypertension (e.g.\nsystolic &gt;180mm Hg or diastolic &gt;100mm Hg);</p><ul><li>Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions&#x2F;illness;</li><li>Any of the following abnormal laboratory tests immediately prior to randomisation:</li></ul><p>serum total bilirubin &gt;2.0 x upper limit of normal (ULN); alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) &gt;2.5 x ULN; alkaline phosphatase (ALP) &gt; 2.5 x ULN; serum creatinine &gt;2.0 x ULN; total white blood cell count (WBC) &lt;2.5 x 10^9&#x2F;L; absolute neutrophil count &lt;1.5 x 10^9&#x2F;L; platelets &lt;100 x 10^9&#x2F;L.</p><ul><li>Unresolved or unstable serious adverse events from prior adjuvant chemotherapy or radiotherapy;</li><li>Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication.\nSubjects with ulcerative colitis are also excluded;</li><li>Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test - urine or serum - within 7 days prior to randomisation);</li><li>Women of childbearing potential and male participants with partners of child bearing potential, including women whose last menstrual period was &lt;1 year ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment (adequate contraceptive measures: intra-uterine device, barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence.\nOral, injectable, or implant hormonal contraceptives are not indicated in this patient population);</li><li>Concomitant use of CYP3A4 inhibitors or inducers.</li></ul>"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/7",
    "value": {
      "city": "Mendoza",
      "status": "NOT_YET_RECRUITING",
      "country": "Argentina",
      "contacts": [
        {
          "name": "GSK Clinical Trials Call Centre",
          "role": "CONTACT",
          "phone": "1 877 379 3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Centre",
      "geoPoint": {
        "lat": -32.88946,
        "lon": -68.84582
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/12/city",
    "value": "Santa Fee"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/12/geoPoint"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/13"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/25/city",
    "value": "Heidelberg"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/25/geoPoint",
    "value": {
      "lat": -37.75,
      "lon": 145.06667
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/26/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/26/zip",
    "value": "7000"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/104/city",
    "value": "Nový Jičín"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/104/geoPoint",
    "value": {
      "lat": 49.59438,
      "lon": 18.01028
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/123/facility",
    "value": "G"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/141/city",
    "value": "La Syene Sur Mer"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/141/geoPoint"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/181/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/184/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/185",
    "value": {
      "zip": "23843",
      "city": "Bad Oldesloe",
      "status": "RECRUITING",
      "country": "Germany",
      "contacts": [
        {
          "name": "GSK Clinical Trials Call Centre",
          "role": "CONTACT",
          "phone": "1 877 379 3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Centre",
      "geoPoint": {
        "lat": 53.81167,
        "lon": 10.37417
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/188/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
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