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| ID | Type | Description | Link |
|---|---|---|---|
| 000 | Other Identifier | CTGTY |
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Adequate bowel cleansing is a critical component in the care of hospitalized patients undergoing colonoscopy. However, inpatient status is a well-established risk factor for inadequate bowel preparation. However, few strategies have been rigorously shown to reduce the risk of inadequate bowel preparation. Moreover, inadequate bowel preparation is frequently related to the poor tolerability of high volumes of bowel preparation in the medically complex and comorbid hospitalized population. Low volume bowel preparations have been developed that have been shown to be noninferior compared to high volume bowel preparation with regards to adequacy of bowel preparation but with improved tolerability. However, the use of low volume bowel preparations for colonoscopies have largely been evaluated in the outpatient setting. In this study, we plan to compare rates of adequate bowel preparation and tolerability of a low volume bowel preparation, MoviPrep, compared to standard high volume bowel preparation, GoLYTELY, in hospitalized patients undergoing colonoscopy. This study promises to highlight low volume bowel preparation as a viable and better tolerated alternative to high volume bowel preparation in hospitalized patients which may ultimately decrease delays in inpatient endoscopy as well as hospital length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MoviPrep | Experimental | For MoviPrep, the dose, schedule, and route of administration are as follows:
|
|
| GoLYTELY | Active Comparator | For GoLYTELY, the dose, schedule, and route of administrate are as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MoviPrep | Drug | Split-dose MoviPrep bowel preparation |
| |
| Golytely |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adequate Bowel Preparation | The Boston-Bowel-Preparation-Scale (BBPS) is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An adequate bowel preparation is defined as a BBPS of 6 or higher with no individual segment scoring less than a 2. | At time of procedure, approximately 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment | BBPS assesses three segments of the colon (left, transverse, right) and scores each segment either a 1, 2, or 3 based on the ability to visualize the mucosa. Higher scores correspond to improved mucosal visibility. | At time of procedure, approximately 45 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darrick K Li, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States | ||
| Yale New-Haven Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26093612 | Background | Yadlapati R, Johnston ER, Gregory DL, Ciolino JD, Cooper A, Keswani RN. Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs. Dig Dis Sci. 2015 Nov;60(11):3482-90. doi: 10.1007/s10620-015-3761-2. Epub 2015 Jun 21. | |
| 32200083 | Background | Fuccio L, Frazzoni L, Spada C, Mussetto A, Fabbri C, Manno M, Aragona G, Zagari RM, Rondonotti E, Manes G, Occhipinti P, Cadoni S, Bazzoli F, Hassan C, Radaelli F; QIPS study group. Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients. Clin Gastroenterol Hepatol. 2021 Feb;19(2):339-348.e7. doi: 10.1016/j.cgh.2020.02.055. Epub 2020 Mar 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MoviPrep | For MoviPrep, the dose, schedule, and route of administration are as follows:
MoviPrep: Split-dose MoviPrep bowel preparation |
| FG001 | GoLYTELY | For GoLYTELY, the dose, schedule, and route of administrate are as follows:
Golytely: Split-dose GoLYTELY bowel preparation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MoviPrep | For MoviPrep, the dose, schedule, and route of administration are as follows:
MoviPrep: Split-dose MoviPrep bowel preparation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adequate Bowel Preparation | The Boston-Bowel-Preparation-Scale (BBPS) is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An adequate bowel preparation is defined as a BBPS of 6 or higher with no individual segment scoring less than a 2. | Posted | Count of Participants | Participants | At time of procedure, approximately 45 minutes |
|
3 days
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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 | MoviPrep | For MoviPrep, the dose, schedule, and route of administration are as follows:
MoviPrep: Split-dose MoviPrep bowel preparation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating or gas | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darrick Li | Yale School of Medicine | (203) 785-7312 | darrick.li@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2023 | Jun 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2023 | Jun 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
| C033608 | Golytely |
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| Drug |
Split-dose GoLYTELY bowel preparation |
|
| Number of Participants With "Excellent" Bowel Preparation | The BBPS is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An excellent bowel preparation is defined as a BBPS score of an 8 or 9. | At time of procedure, approximately 45 minutes |
| Cecal Intubation | Number of participants with colonoscopies during which the cecum is successfully reached | At time of procedure, approximately 45 minutes |
| Cecal Intubation Time | Time from insertion of colonoscopy to reaching the cecum | At time of procedure, approximately 45 minutes |
| Colonoscopy Withdrawal Time | Time from reaching the cecum to complete withdrawal of the colonoscope | At time of procedure, approximately 45 minutes |
| Time to Colonoscopy | The time from when the patient started the bowel preparation to the colonoscopy procedure itself. | From start of prep to time of procedure, up to 21 hours |
| Hospital Length of Stay | Time from admission to discharge | After study completion, an average of 10 days |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term from a scale of 1-5, with increasing score corresponding to increasing AE severity. | Through study completion, an average of 3 days |
| Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How much of the bowel preparation was left in the bottle after drinking it to your best effort?" | Immediately prior to procedure |
| Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How tolerable did you find the bowel prep?" | Immediately prior to procedure |
| Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Based on your current experience, would you be willing to drink the same prep again if you need another colonoscopy in the future?" | Immediately prior to procedure |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bad taste in mouth" | Immediately prior to procedure |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Gastric fullness" | Immediately prior to procedure |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Lack of sleep from excessive bathroom trips" | Immediately prior to procedure |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Nausea/vomiting" | Immediately prior to procedure |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bloating/abdominal distension/gas" | Immediately prior to procedure |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Abdominal pain/cramps" | Immediately prior to procedure |
| Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Headache" | Immediately prior to procedure |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| 31683057 | Background | Spadaccini M, Frazzoni L, Vanella G, East J, Radaelli F, Spada C, Fuccio L, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Van Hooft JE, Dumonceau JM, Marmo C, Alfieri S, Chandrasekar VT, Sharma P, Rex DK, Repici A, Hassan C. Efficacy and Tolerability of High- vs Low-Volume Split-Dose Bowel Cleansing Regimens for Colonoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2020 Jun;18(7):1454-1465.e14. doi: 10.1016/j.cgh.2019.10.044. Epub 2019 Nov 1. |
| 30986186 | Background | Garber A, Sarvepalli S, Burke CA, Bhatt A, Ibrahim M, McMichael J, Morris-Stiff G, Rizk MK, Vargo JJ, Rothberg MB. Modifiable Factors Associated with Quality of Bowel Preparation Among Hospitalized Patients Undergoing Colonoscopy. J Hosp Med. 2019 May;14(5):278-283. doi: 10.12788/jhm.3173. |
| 24953203 | Background | Patel M, Staggs E, Thomas CS, Lukens F, Wallace M, Almansa C. Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire. Dig Liver Dis. 2014 Sep;46(9):808-12. doi: 10.1016/j.dld.2014.05.020. Epub 2014 Jun 19. |
| 41128725 | Derived | Xiao K, Khan F, Link R, Dominguez-Diaz A, Ameyaw P, Alexis J, Tai CH, Assalone V, Nasufi M, Hughes ML, Loeser C, Hung K, Li DK. Efficacy and Safety of Low Volume Bowel Preparation for Colonoscopy in Hospitalized Patients: A Randomized Noninferiority Trial. J Clin Gastroenterol. 2025 Oct 24. doi: 10.1097/MCG.0000000000002269. Online ahead of print. |
| No colonoscopy video |
|
| Protocol Violation |
|
| BG001 | GoLYTELY | For GoLYTELY, the dose, schedule, and route of administrate are as follows:
Golytely: Split-dose GoLYTELY bowel preparation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Count of Participants | Participants |
|
| Participant Baseline ASA Score | The ASA score is a subjective assessment of a patient's overall health and fitness for anesthesia and surgery, according to the American Society of Anesthesiologists (ASA). | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
| Medication use | Count of Participants | Participants |
|
| Indication for colonoscopy | More than one indication per participant is possible. | Count of Participants | Participants |
|
| Patient Location | Count of Participants | Participants |
|
| Diet Prior to Colonoscopy | Count of Participants | Participants |
|
| OG001 | GoLYTELY | For GoLYTELY, the dose, schedule, and route of administrate are as follows:
Golytely: Split-dose GoLYTELY bowel preparation |
|
|
|
| Secondary | Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment | BBPS assesses three segments of the colon (left, transverse, right) and scores each segment either a 1, 2, or 3 based on the ability to visualize the mucosa. Higher scores correspond to improved mucosal visibility. | Posted | Mean | Standard Deviation | score on a scale | At time of procedure, approximately 45 minutes |
|
|
|
| Secondary | Number of Participants With "Excellent" Bowel Preparation | The BBPS is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An excellent bowel preparation is defined as a BBPS score of an 8 or 9. | Posted | Count of Participants | Participants | At time of procedure, approximately 45 minutes |
|
|
|
| Secondary | Cecal Intubation | Number of participants with colonoscopies during which the cecum is successfully reached | Posted | Count of Participants | Participants | At time of procedure, approximately 45 minutes |
|
|
|
| Secondary | Cecal Intubation Time | Time from insertion of colonoscopy to reaching the cecum | Posted | Median | Inter-Quartile Range | Minutes | At time of procedure, approximately 45 minutes |
|
|
|
| Secondary | Colonoscopy Withdrawal Time | Time from reaching the cecum to complete withdrawal of the colonoscope | Posted | Median | Inter-Quartile Range | Minutes | At time of procedure, approximately 45 minutes |
|
|
|
| Secondary | Time to Colonoscopy | The time from when the patient started the bowel preparation to the colonoscopy procedure itself. | Posted | Median | Inter-Quartile Range | Hours | From start of prep to time of procedure, up to 21 hours |
|
|
|
| Secondary | Hospital Length of Stay | Time from admission to discharge | Posted | Median | Inter-Quartile Range | days | After study completion, an average of 10 days |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term from a scale of 1-5, with increasing score corresponding to increasing AE severity. | Posted | Count of Participants | Participants | Through study completion, an average of 3 days |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How much of the bowel preparation was left in the bottle after drinking it to your best effort?" | Posted | Count of Participants | Participants | Immediately prior to procedure |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How tolerable did you find the bowel prep?" | Posted | Count of Participants | Participants | Immediately prior to procedure |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Based on your current experience, would you be willing to drink the same prep again if you need another colonoscopy in the future?" | Posted | Count of Participants | Participants | Immediately prior to procedure |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bad taste in mouth" | Posted | Count of Participants | Participants | Immediately prior to procedure |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Gastric fullness" | Posted | Count of Participants | Participants | Immediately prior to procedure |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Lack of sleep from excessive bathroom trips" | Posted | Count of Participants | Participants | Immediately prior to procedure |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Nausea/vomiting" | Posted | Count of Participants | Participants | Immediately prior to procedure |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bloating/abdominal distension/gas" | Posted | Count of Participants | Participants | Immediately prior to procedure |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Abdominal pain/cramps" | Posted | Count of Participants | Participants | Immediately prior to procedure |
|
|
|
| Secondary | Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7 | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Headache" | Posted | Count of Participants | Participants | Immediately prior to procedure |
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|
|
| 0 |
| 202 |
| 3 |
| 202 |
| 104 |
| 202 |
| EG001 | GoLYTELY | For GoLYTELY, the dose, schedule, and route of administrate are as follows:
Golytely: Split-dose GoLYTELY bowel preparation | 0 | 210 | 2 | 210 | 121 | 210 |
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal pain or cramping | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea or vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypokalemia | Renal and urinary disorders | Systematic Assessment |
|
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| Left |
|
| 50-75% |
|
| ≥75% |
|
| Unknown/Did not answer |
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| Somewhat difficult |
|
| Very difficult |
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| Unknown/DId not answer |
|
| Mostly willing |
|
| Unknown/Did not answer |
|
| Moderate |
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| Severe |
|
| Unknown/Did not answer |
|
| Moderate |
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| Severe |
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| Unknown/Did not answer |
|
| Moderate |
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| Severe |
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| Unknown/Did not answer |
|
| Moderate |
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| Severe |
|
| Unknown/Did not answer |
|
| Moderate |
|
| Severe |
|
| Unknown/Did not answer |
|
| Moderate |
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| Severe |
|
| Unknown/Did not answer |
|
| Moderate |
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| Severe |
|
| Unknown/Did not answer |
|