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| ID | Type | Description | Link |
|---|---|---|---|
| RD006616 | Other Identifier | Roche Molecular Systems, Inc. |
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| Name | Class |
|---|---|
| Roche Molecular Systems, Inc | INDUSTRY |
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This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG).
The study is designed as a block randomized, controlled 2-arm prospective study. The study targets to enroll approximatively 348 participants at increased risk of sexually transmitted infections (STIs)-participants who have known contact with CT/NG/MG (including participants who report knowledge or suspicion of STI exposure, despite the uncertainty of the specific STI pathogen or contact testing results), or participants with symptoms suggestive of STI-to participate in this study. Participants who give consent will provide demographic information and urogenital specimen(s) for CT/NG/MG testing on the cobas® liat system and for external laboratory-polymerase chain reaction (EL-PCR) testing. Participants will be randomized in a 1:1 ratio in blocks (of multiples of 2) stratified by the site to either of the following arms:
In both arms, the clinician will see and evaluate the participant and will complete a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter. The critical difference between the arms is that the clinician in the POC arm will be provided POC test results upon which they may choose to base their clinical decisions, whereas the SOC arm will not receive POC test results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SOC) Arm: Standard Practice | Other | In the SOC arm, the clinician will evaluate the participant based on standard practice. |
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| Point of Care (POC) Arm: cobas® liat CT/NG/MG | Experimental | In the POC arm, the clinician will evaluate the participant and will be provided POC test results upon which they may choose to base their clinical decisions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cobas® liat CT/NG/MG nucleic acid test | Diagnostic Test | The cobas® CT/NG/MG nucleic acid test for use on the cobas® Liat® System is an investigational, automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) nucleic acid in male/female urine and vaginal swabs (clinician-collected and self-collected) in cobas® PCR Media. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG) | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on the CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. | On the day of the medical encounter (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Given Inappropriate Treatment for CT Infection | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zune Huynh, MD | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco City Clinic | San Francisco | California | 94103 | United States | ||
| Planned Parenthood of Northern, Central, and Southern New Jersey, Inc. |
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The clinicians referred to as any health care professional (e.g., doctor, provider, pharmacist, nurse, etc.) involved with performing diagnostic tests on participants, interpreting the results, and providing participant care were not enrolled in the study. No participant flow/baseline/safety data was collected for the clinicians. The clinician only completed the Clinician Satisfaction with Diagnostic Test Questionnaire (CSDT-Q).
A total of 331 participants at increased risk of sexually transmitted infection (STIs) who have known contact with Liat Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG)/ Mycoplasma genitalium (MG) or participants with symptoms suggestive of STI took part in the study at 4 sites in the United States of America from 29 July 2024 to 28 May 2025. One participant was excluded from analysis due to invalid results.
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| ID | Title | Description |
|---|---|---|
| FG000 | Point of Care Arm | Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2024 | May 27, 2026 |
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| Standard of Care (SOC): Clinician's Standard Practice | Other | Standard of care (SOC) is defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. |
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| On the day of the medical encounter (Day 1) |
| Percentage of Participants Given Inappropriate Treatment for NG Infection | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. | On the day of the medical encounter (Day 1) |
| Percentage of Participants Given Inappropriate Treatment for MG Infection | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. | On the day of the medical encounter (Day 1) |
| Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q) | The CSDT- Questionnaire assessed satisfaction with the test and SOC based on responses to the following: ease of use, time taken to perform, speed of results, ease of result interpretation, impact on the care plan, impact on consultations, impact on workload/workflow, and guidance and training, using a 5-point scale ranging from very satisfied to very dissatisfied. Only response categories with non-zero values are reported. Percentages have been rounded off. | Baseline until end of study (approximately 9.9 months) |
| Percentage of Clinicians With Confidence Scores for SOC and POC According to the CSDT-Q | The CSDT- Questionnaire assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off. | Baseline until end of study (approximately 9.9 months) |
| Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q) | The PSDT- Questionnaire assessed satisfaction with the diagnostic test process based on responses to the following: overall visit satisfaction, information provision, ease of completion, time taken to perform, speed of results, method of results delivery, ease of understanding, accuracy, impact on clinical pathway, overall satisfaction, and satisfaction with sample or measurement collection bases on as: comfort, convenience, type of sample or measurement, person collecting sample or measurement, hygiene using a 5-point scale ranging from very satisfied to very dissatisfied. Percentages have been rounded off. | On the day of the medical encounter (Day 1) |
| Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q | The PSDT-Q assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off. | Baseline until end of study (approximately 9.9 months) |
| Hamilton Square |
| New Jersey |
| 08690 |
| United States |
| Planned Parenthood of Northern, Central and Southern New Jersey | Perth Amboy | New Jersey | 08861 | United States |
| Baylor Scott & White Health - Kileen | Killeen | Texas | 76543 | United States |
| FG001 | Standard of Care Arm | Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the Centers for Disease Control and Prevention (CDC) guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter. |
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| NOT COMPLETED |
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Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by external laboratory-polymerase chain reaction (EL-PCR).
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| ID | Title | Description |
|---|---|---|
| BG000 | Point of Care Arm | Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter. |
| BG001 | Standard of Care Arm | Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the Centers for Disease Control and Prevention (CDC) guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Secondary | Percentage of Participants Given Inappropriate Treatment for CT Infection | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. | Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR. | Posted | Number | percentage of participants | On the day of the medical encounter (Day 1) |
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| Secondary | Percentage of Participants Given Inappropriate Treatment for NG Infection | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. | Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR. | Posted | Number | percentage of participants | On the day of the medical encounter (Day 1) |
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| Secondary | Percentage of Participants Given Inappropriate Treatment for MG Infection | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. | Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR. | Posted | Number | percentage of participants | On the day of the medical encounter (Day 1) |
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| Secondary | Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q) | The CSDT- Questionnaire assessed satisfaction with the test and SOC based on responses to the following: ease of use, time taken to perform, speed of results, ease of result interpretation, impact on the care plan, impact on consultations, impact on workload/workflow, and guidance and training, using a 5-point scale ranging from very satisfied to very dissatisfied. Only response categories with non-zero values are reported. Percentages have been rounded off. | All clinicians involved in the study who completed a CSDT questionnaire. Overall number is the number of clinicians with who responded to the CSDT questionnaire. Number analyzed is the number of clinicians who answered specific questions of the questionnaire. | Posted | Number | percentage of clinicians | Baseline until end of study (approximately 9.9 months) |
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| Secondary | Percentage of Clinicians With Confidence Scores for SOC and POC According to the CSDT-Q | The CSDT- Questionnaire assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off. | All clinicians involved in the study who completed a CSDT questionnaire. Overall number is the number of clinicians who responded to the CSDT questionnaire. | Posted | Number | percentage of clinicians | Baseline until end of study (approximately 9.9 months) |
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| Secondary | Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q) | The PSDT- Questionnaire assessed satisfaction with the diagnostic test process based on responses to the following: overall visit satisfaction, information provision, ease of completion, time taken to perform, speed of results, method of results delivery, ease of understanding, accuracy, impact on clinical pathway, overall satisfaction, and satisfaction with sample or measurement collection bases on as: comfort, convenience, type of sample or measurement, person collecting sample or measurement, hygiene using a 5-point scale ranging from very satisfied to very dissatisfied. Percentages have been rounded off. | Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR. Number analyzed is the number of participants who answered specific questions of the PSDT questionnaire. | Posted | Number | percentage of participants | On the day of the medical encounter (Day 1) |
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| Secondary | Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q | The PSDT-Q assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off. | Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR. Overall number is the number of participants who answered the 'Accuracy' question of the PSDT-Q. | Posted | Number | percentage of participants | Baseline until end of study (approximately 9.9 months) |
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| Primary | Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG) | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on the CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. | Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR. | Posted | Number | percentage of participants | On the day of the medical encounter (Day 1) |
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Up to 9.9 months
Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Point of Care Arm | Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter. | 0 | 160 | 0 | 160 | 0 | 160 |
| EG001 | Standard of Care Arm | Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the Centers for Disease Control and Prevention (CDC) guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter. | 0 | 170 | 0 | 170 | 0 | 170 |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Roche Molecular Systems, Inc. | (925) 730-8000 | global.scientific-communications@roche.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2025 | May 27, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
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Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/SOC defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter. |
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