{
"info": {
"nct_id": "NCT01994382",
"official_title": "A Phase 1/2a Open-Label, Multi-Dose, Multi-Center Escalation and Exploratory Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) or B-Cell or T-Cell Non-Hodgkin Lymphoma (NHL)",
"inclusion_criteria": "Phase 1 Inclusion\n\n• Participant at least 18 years of age with histologically confirmed CLL/SLL or B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma [DLBCL], FL, mantle cell lymphoma [MCL], marginal zone lymphoma [MZL], lymphoplasmacytic lymphoma).\n\nPhase 2a Inclusion\n\n* Histological evidence: FL Grade 1-3A, with relapsed or refractory disease; aggressive NHL (aNHL), defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, peripheral T-cell lymphoma (PTCL), or cutaneous T-cell lymphoma (CTCL) (with mycosis fungoides [MF]/Sézary Syndrome [SS]) with relapsed or refractory disease\n* Received B-cell receptor (BCR) and/or BCL2 inhibitors and were intolerant or had relapsed/refractory disease afterwards\n* Prior treatment for lymphoid malignancy for progressive /refractory disease\n* ≥1 prior regimen (minimum 2 cycles) with antibody conjugate/cytotoxic chemotherapy.\n* Measurable disease defined as: ≥1 lesion that measures ≥1.5 centimeter (cm) single dimension via computed tomography (CT), CT/positive-emission tomography (PET) with nodal or mass lesions; quantifiable circulating tumor cells; and for CTCL: Modified Severity Weighted Assessment Tool (mSWAT) >0\n* Ability to provide diagnostic reports\n\nGeneral Inclusion\n\n* Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1\n* Hematologic absolute neutrophil count (ANC) >1000/microliter (uL) and platelet >75,000/uL\n* Creatinine levels as specified by Investigator\n* Bilirubin <2.0 mg/deciliter [dL] (if Gilberts then <2.5 mg/dL) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2.5*ULN\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Richter's syndrome, Burkitt's lymphoma, or Burkitt-like Lymphoma (transformed DLBCL from follicular NHL are eligible)\n* Prior transplant with stem cell infusion within 90 days of Day 1 or active graft-versus-host treatment within 8 weeks of Day 1\n* Prior therapy with Spleen Tyrosine Kinase (SYK) inhibitors\n* Chronic treatment with strong CYP3A4 inhibitor/inducer\n* Known lymphomatous involvement of the central nervous system (CNS)\n* Persistent, unresolved National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 ≥Grade 2, previous drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy).\n* Prior monoclonal antibody (including alemtuzumab), radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks of Day 1\n* For CTCL: (total skin electron beam therapy [TSEBT]) within 12 weeks, or initiation of topical steroid, nitrogen mustard, or topical retinoid within 2 weeks. Stable topical regimen for ≥4 weeks prior to Day 1 allowed.\n* Known carrier or infection for human immunodeficiency virus (HIV)/hepatitis B or C. If hepatitis C virus (HCV) antibody (ab)+, must be polymerase chain reaction (PCR)- to be eligible. If hepatitis B virus (HBV) ab+, must be hepatitis B surface antigen (HBsAg)- or undetectable HBV deoxyribonucleic acid (DNA) to be eligible.\n* Active infection requiring systemic treatment,\n* Significant gastrointestinal (GI) disease, previous major gastric/bowel surgery, difficulty swallowing, or malabsorption syndrome\n* Major surgery within 4 weeks\n* Previous malignancies within 2 years unless relapse risk is small (<5%).\n* Current use of systemic steroids >20 mg QD prednisone (or equivalent)\n* Breastfeeding or pregnant (intention to become) females or participation in other clinical trials",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "• Participant at least 18 years of age with histologically confirmed CLL/SLL or B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma [DLBCL], FL, mantle cell lymphoma [MCL], marginal zone lymphoma [MZL], lymphoplasmacytic lymphoma).",
"criterions": [
{
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"Participant at least 18 years of age"
],
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"requirement_type": "minimum",
"expected_value": {
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"value": 18
}
},
{
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"histologically confirmed CLL/SLL"
],
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"requirement_type": "confirmation",
"expected_value": true
},
{
"exact_snippets": [
"histologically confirmed",
"B-cell non-Hodgkin lymphoma"
],
"criterion": "B-cell non-Hodgkin lymphoma",
"requirement_type": "confirmation",
"expected_value": true
},
{
"exact_snippets": [
"diffuse large B-cell lymphoma [DLBCL]"
],
"criterion": "diffuse large B-cell lymphoma",
"requirement_type": "confirmation",
"expected_value": true
},
{
"exact_snippets": [
"FL"
],
"criterion": "FL",
"requirement_type": "confirmation",
"expected_value": true
},
{
"exact_snippets": [
"mantle cell lymphoma [MCL]"
],
"criterion": "mantle cell lymphoma",
"requirement_type": "confirmation",
"expected_value": true
},
{
"exact_snippets": [
"marginal zone lymphoma [MZL]"
],
"criterion": "marginal zone lymphoma",
"requirement_type": "confirmation",
"expected_value": true
},
{
"exact_snippets": [
"lymphoplasmacytic lymphoma"
],
"criterion": "lymphoplasmacytic lymphoma",
"requirement_type": "confirmation",
"expected_value": true
}
]
},
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"value": 18
}
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},
{
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],
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},
{
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},
{
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"FL"
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},
{
"exact_snippets": [
"mantle cell lymphoma [MCL]"
],
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"expected_value": true
},
{
"exact_snippets": [
"marginal zone lymphoma [MZL]"
],
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"requirement_type": "confirmation",
"expected_value": true
},
{
"exact_snippets": [
"lymphoplasmacytic lymphoma"
],
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"requirement_type": "confirmation",
"expected_value": true
}
]
},
{
"exact_snippets": [
"histologically confirmed",
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],
"criterion": "B-cell non-Hodgkin lymphoma",
"requirement_type": "confirmation",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "* Histological evidence: FL Grade 1-3A, with relapsed or refractory disease; aggressive NHL (aNHL), defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, peripheral T-cell lymphoma (PTCL), or cutaneous T-cell lymphoma (CTCL) (with mycosis fungoides [MF]/Sézary Syndrome [SS]) with relapsed or refractory disease",
"criterions": [
{
"exact_snippets": [
"Histological evidence: FL Grade 1-3A"
],
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"requirement_type": "histological evidence",
"expected_value": [
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"2",
"3A"
]
},
{
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]
},
{
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],
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"requirement_type": "definition",
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"FL Grade 3B",
"MCL",
"transformed NHL"
]
},
{
"exact_snippets": [
"relapsed disease"
],
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},
{
"exact_snippets": [
"CLL/SLL"
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"expected_value": true
},
{
"exact_snippets": [
"peripheral T-cell lymphoma (PTCL)"
],
"criterion": "peripheral T-cell lymphoma",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"cutaneous T-cell lymphoma (CTCL) (with mycosis fungoides [MF]/Sézary Syndrome [SS])"
],
"criterion": "cutaneous T-cell lymphoma",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"relapsed or refractory disease"
],
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}
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{
"and_criteria": [
{
"and_criteria": [
{
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],
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],
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{
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}
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{
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{
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{
"and_criteria": [
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"exact_snippets": [
"cutaneous T-cell lymphoma (CTCL) (with mycosis fungoides [MF]/Sézary Syndrome [SS])"
],
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"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
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"identified_line": {
"line": "* Received B-cell receptor (BCR) and/or BCL2 inhibitors and were intolerant or had relapsed/refractory disease afterwards",
"criterions": [
{
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"Received B-cell receptor (BCR) and/or BCL2 inhibitors"
],
"criterion": "B-cell receptor (BCR) and/or BCL2 inhibitors",
"requirement_type": "receipt",
"expected_value": true
},
{
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"intolerant"
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"requirement_type": "presence",
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},
{
"exact_snippets": [
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}
]
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],
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},
"else_criteria": null
}
},
{
"identified_line": {
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{
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],
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{
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}
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}
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}
},
{
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}
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}
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},
{
"identified_line": {
"line": "* Ability to provide diagnostic reports",
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{
"exact_snippets": [
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],
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"expected_value": true
}
]
},
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]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1",
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{
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}
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},
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}
]
}
},
{
"identified_line": {
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{
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},
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{
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],
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}
},
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}
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},
{
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},
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}
},
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},
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}
},
{
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},
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}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Prior transplant with stem cell infusion within 90 days of Day 1 or active graft-versus-host treatment within 8 weeks of Day 1",
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{
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],
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}
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}
]
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}
]
},
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{
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"exact_snippets": [
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],
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"line": "* Prior therapy with Spleen Tyrosine Kinase (SYK) inhibitors",
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],
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}
]
},
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}
}
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"strong CYP3A4 inhibitor/inducer"
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]
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}
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"line": "* Known lymphomatous involvement of the central nervous system (CNS)",
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{
"exact_snippets": [
"lymphomatous involvement of the central nervous system (CNS)"
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}
]
},
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"lymphomatous involvement of the central nervous system (CNS)"
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}
},
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"value": 2
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{
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"alopecia"
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"requirement_type": "exclusion",
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},
{
"exact_snippets": [
"erectile impotence"
],
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},
{
"exact_snippets": [
"hot flashes"
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"criterion": "hot flashes",
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"expected_value": true
},
{
"exact_snippets": [
"libido"
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"criterion": "libido",
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"expected_value": true
},
{
"exact_snippets": [
"neuropathy"
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"expected_value": true
}
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"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
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"and_criteria": [
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"and_criteria": [
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"operator": ">=",
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},
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}
},
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"identified_line": {
"line": "* Prior monoclonal antibody (including alemtuzumab), radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks of Day 1",
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"exact_snippets": [
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"requirement_type": "prior use",
"expected_value": true
},
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"including alemtuzumab"
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{
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},
{
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{
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"within 3 weeks of Day 1"
],
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"operator": "<=",
"value": 3
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}
},
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},
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],
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},
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],
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},
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],
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},
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],
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]
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"operator": "<=",
"value": 2
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]
}
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"operator": "<",
"value": 5
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}
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">20 mg QD prednisone (or equivalent)"
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},
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"criterion": "pregnancy",
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},
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"criterion": "intention to become pregnant",
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},
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]
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},
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},
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},
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}
},
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"exact_snippets": [
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},
{
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},
{
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}
]
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{
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"exact_snippets": [
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},
{
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},
{
"exact_snippets": [
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]
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},
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],
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"identified_line": {
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}