{"text_format":"3","workbook":"xls","n_sheets":20,"sheets":["Enrollment","Enrollment Status","Treatment","Forms","Demographics","InclusionExclusion","AE Summary","SAE Summary","AETerms Including Deterioration","SAETerms","AE SummarySeverity","SAE SummarySeverity","AESummaryRelat","SAE SummaryRelat","SAEList","Death-Closed","PAS and others","FOIS","NIHSS","NIHSS-motor"],"not_rendered":{"charts":1,"external_links":1,"defined_names":18},"read":"whole","date_system":"1900","formulas":"cached_only"}

{"sheet":"Enrollment","index":0,"n_rows":22,"n_cols":20,"rows_kept":22,"merged":[[0,0,0,8],[1,0,1,8],[3,0,3,2],[4,0,4,2],[6,3,6,13],[25,16,25,26]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
[{"$nulls":3},"Figure 1: Enrollment: Actual vs. Expected"]
{"$rows_empty":8}
[{"$nulls":16},1,0,null,"<1"]
[{"$nulls":16},5,3,null,"1 to 3"]
[{"$nulls":16},9,10,null,"3 to 6"]
[{"$nulls":16},15,16,null,"6 to 12"]
[{"$nulls":16},27,20,null,"12 to 18"]
[{"$nulls":16},39,30,null,"18 to 24"]
[{"$nulls":16},85,42,null,"24 to 48"]

{"sheet":"Enrollment Status","index":1,"n_rows":46,"n_cols":11,"rows_kept":46,"merged":[[0,0,0,8],[1,0,1,8],[3,0,3,2],[4,0,4,2],[6,0,6,8],[7,1,7,8],[8,1,8,2],[8,3,8,4],[8,5,8,6],[8,7,8,8],[8,10,8,21],[9,10,9,21],[10,10,10,21],[26,1,26,2],[26,3,26,4],[26,5,26,6],[26,7,26,8],[28,1,28,2],[28,3,28,4],[28,5,28,6],[28,7,28,8],[29,1,29,2],[29,3,29,4],[29,5,29,6],[29,7,29,8],[31,1,31,2],[31,3,31,4],[31,5,31,6],[31,7,31,8],[33,1,33,2],[33,3,33,4],[33,5,33,6],[33,7,33,8],[34,1,34,2],[34,3,34,4],[34,5,34,6],[34,7,34,8],[42,0,42,8],[44,0,44,1],[45,0,45,3]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 1.1: Participant Enrollment Status by Treatment Group"]
[]
[null,"Treatment 1",null,"Treatment 2",null,"Treatment 3",null,"Overall",null,null,"NOTE:  Tables will be labeled as \"Treatment 1\", \"Treatment 2\", \"Treatment 3\" in case of inadvertent misplacement of the report."]
[{"$nulls":7},"N","%*",null,"            When the report is sent, a separate e-mail detailing the actual treatments represented by \"Treatment 1\", \"Treatment 2\", "]
["Screened","-","-","-","-","-","-",328,100,null,"            \"Treatment 3\" will be provided."]
["         Screening Failures*","-","-","-","-","-","-",214,65]
["              No suspected unilateral hemispheric infarction","-","-","-","-","-","-",56,17]
["              Stroke onset <25 or >144 hours before anticipated study treatment","-","-","-","-","-","-",23,7]
["              Bedside swallow test was conducted","-","-","-","-","-","-",16,5]
["              No dysphagia suspected","-","-","-","-","-","-",101,31]
["              MRI contraindications","-","-","-","-","-","-",11,3]
["              tDCS contraindications","-","-","-","-","-","-",4,1]
["             Age > 90","-","-","-","-","-","-",3,1]
[null,"N","%**","N","%**","N","%**","N","%**"]
["Randomized",15,100,13,100,14,100,42,100]
["         Active ",1,7,1,8,2,14,4,10]
["         Completed or Prematurely Withdrawn",14,93,12,92,12,86,38,90]
["         Treated",15,100,13,100,14,100,42,100]
["PAS Scores"]
["PAS scores (4-6)"]
["     N",3,null,4,null,4,null,11]
["     Mean SD)",4,"(0)",5,"(0.8)",4,"(0)",4.4,"(0.7)"]
["     Median",4,null,5,null,4,null,4]
["     Minimum,Maximum","4,4",null,"4,6",null,"4,4",null,"4,6"]
["PAS scores (7-8)"]
["     N",11,null,10,null,10,null,31]
["     Mean SD)",7.8,"(0.4)",7.3,"(0.5)",7.5,"(0.5)",7.6,"(0.5)"]
["     Median",8,null,7,null,7,null,8]
["     Minimum,Maximum","7,8",null,"7,8",null,"7,8",null,"7,8"]
[null,"N","%***","N","%***","N","%***","N","%***"]
["Study Completion Status"]
["Subject Completed All 10 Sessions",5,38,8,57,5,33,18,43]
["Subject Completed 1 Month Follow-up",12,92,12,86,14,93,38,90]
["Subject Died",1,8,1,7,1,7,3,7]
["Subject Withdrew Consent",0,0,0,0,0,0,0,0]
["Lost to Follow-up",0,0,1,7,0,0,1,2]
["Of the 38 patients completing 1-month follow-up, 17 completed all 10 sessions and 21 did not (1013(T3), 1017(T2), 1022(T1), 1023(T1), 1030(T2), 1048(T1), 1049(T2), 1051(T2), 1054(T1), 1067(T1), 1077 (T1), 1098 (T2), 1099 (T3), 1100 (T2), 1101 (T2),  1140 (T3), 1160 (T1), 1182 (T3), 1211 (T2), 1290 (T1), and 1321(T1)). Three patients were died,  one (1028 (T3)) completed the all 10 seesions and did not complete 1-month follow-up, and the other two (ID 1041(T2) and 1109(T1)) did not compete all 10 sessions and 1 month of follow-up. One Subject (1065(T3)) was lost follow-up and did not omplete all 10 sessions and 1 month of follow-up."]
["*% of screened participants"]
["**% of participants who are randomized"]
["*** % of participants who completed or prematurely withdrew"]

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["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 1.2: Number of Participants Receiving Treatment - Randomized Participants"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Overall     (N=42)"]
["Study Day","N","%","N","%","N","%","N","%"]
["Session 1",15,100,14,100,14,100,42,100]
["Session 2",15,100,14,100,14,100,42,100]
["Session 3",14,93,14,100,14,100,41,98]
["Session 4",14,93,14,100,14,100,41,98]
["Session 5",14,93,14,100,14,100,41,98]
["Session 6",11,73,14,100,14,100,34,81]
["Session 7",11,73,11,79,11,79,30,71]
["Session 8",11,73,11,79,11,79,29,69]
["Session 9",6,40,10,71,10,71,22,52]
["Session 10",5,33,8,57,8,57,18,43]
["At Least One Session",15,100,14,100,14,100,42,100]
["Of the 42 randomized and treated patients, 17 completed all 10 sessions, 21 did not (1013(T3), 1017(T2), 1022(T1), 1023(T1), 1030(T2), 1048(T1), 1049(T2), 1051(T2), 1054(T1), 1067(T1), 1077 (T1), 1098 (T2), 1099 (T3), 1100 (T2), 1101 (T2),  1140 (T3), 1160 (T1), 1182 (T3), 1211 (T2), 1290 (T1), and 1321(T1)); three patients were died and one was lost follow-up."]
["Note: Percentages are based on number of randomized participants."]

{"sheet":"Forms","index":3,"n_rows":15,"n_cols":4,"rows_kept":15,"merged":[[0,0,0,8],[1,0,1,8],[3,0,3,2],[4,0,4,2],[6,0,6,8],[7,1,7,8],[14,0,14,3]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 1.3: Data Compliance - Randomized Participants"]
[]
["Form","# Forms Expected","# Forms Submitted","% of  Missing Forms*"]
["Screening",42,42,0]
["Inclusion/Exclusion",42,42,0]
["Randomization",42,42,0]
["Demographics",42,42,0]
["All (total)",168,168,0]
["*Percentages are based on number of forms submitted."]

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["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 2: Baseline Demographic Characteristics by Treatment Group - Randomized Participants"]
[]
["Characteristic",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Overall     (N=42)"]
["Gender",null,"N","(%)","N","(%)","N","(%)","N","(%)"]
["     Male ",null,9,60,5,38,11,79,25,60]
["     Female ",null,6,40,8,62,3,21,17,40]
["Age"]
["     N ",null,15,null,13,null,14,null,42]
["     Mean (SD)",null,73,"(14.1)",72,"(13.3)",68,"(12.6)",71,"(13.2)"]
["     Median",null,74,null,74,null,69,null,73]
["     Minimum, Maximum",null,"40,90",null,"51,90",null,"50,86",null,"40,90"]
["Race*",null,"N","(%)","N","(%)","N","(%)","N","(%)"]
["     American Indian or Alaska Native",null,0,0,0,0,0,0,0,0]
["     Asian",null,0,0,0,0,2,14,2,5]
["     Black or African American",null,0,0,2,15,3,21,5,12]
["     Native Hawaiian or Other Pacific Islander",null,0,0,0,0,0,0,0,0]
["     White",null,14,93,11,85,9,64,34,81]
["     Unknown",null,1,7,0,0,0,0,1,2]
["Ethnicity",null,"N","(%)","N","(%)","N",null,"N","(%)"]
["      Hispanic or Latino",null,1,7,0,0,2,14,3,7]
["      Not Hispanic or Latino",null,14,93,13,100,12,86,39,93]
["Previous Stroke",null,"N","(%)","N","(%)","N",null,"N","(%)"]
["      Yes",null,2,13,2,15,1,7,5,12]
["      No ",null,13,87,11,85,13,93,37,88]
["Baseline PAS"]
["     N",null,15,null,13,null,14,null,42]
["     Mean (SD)",null,{"v":4,"d":"4.0"},"(1.5)",4.1,"(1.1)",{"v":4,"d":"4.0"},"(1.2)",{"v":4,"d":"4.0"},"(1.3)"]
["     Median",null,3.7,null,4.3,null,4.2,null,3.8]
["     Minimum, Maximum",null,"2.4,7.4",null,"1.6,5.6",null,"2.4,6.4",null,"1.6,7.4"]
["Baseline FOIS"]
["     N",null,15,null,13,null,14,null,42]
["     Mean (SD)",null,2.7,"(1.3)",2.8,"(1.5)",3.3,"(1.6)",2.9,"(1.5)"]
["     Median",null,{"v":2,"d":"2.0"},null,{"v":4,"d":"4.0"},null,2.5,null,{"v":2,"d":"2.0"}]
["     Minimum, Maximum",null,"1,5",null,"1,6",null,"1,6",null,"1,6"]
["Baseline NIHSS"]
["     N",null,15,null,13,null,14,null,42]
["     Mean (SD)",null,11.5,"(5.0)",12.5,"(6.1)",12.8,"(4.7)",12.3,"(5.2)"]
["     Median",null,13,null,13,null,11.5,null,12.5]
["     Minimum, Maximum",null,"3,20",null,"5,24",null,"6,21",null,"3,24"]
["Baseline NIHSS Motor Left Arm"]
["     N",null,15,null,13,null,14,null,42]
["     Mean (SD)",null,1.8,"(2.0)",1.2,"(1.7)",0.8,"(1.6)",1.3,"(1.8)"]
["     Median",null,0.5,null,0,null,0,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,2",null,"0,0",null,"0,4"]
["Baseline NIHSS Motor Right Arm"]
["     N",null,15,null,13,null,14,null,42]
["     Mean (SD)",null,0.7,"(1.3)",{"v":1,"d":"1.0"},"(1.3)",2.1,"(1.8)",1.3,"(1.6)"]
["     Median",null,0,null,0,null,2,null,0.25]
["     Minimum, Maximum",null,"0,1",null,"0,2",null,"0,4",null,"0,3"]
["Baseline NIHSS Motor Left Leg"]
["     N",null,15,null,13,null,14,null,42]
["     Mean (SD)",null,1.3,"(1.6)",1.5,"(1.7)",0.5,"(0.9)",1.1,"(1.5)"]
["     Median",null,0,null,0,null,0,null,0]
["     Minimum, Maximum",null,"0,2",null,"0,3",null,"0,1",null,"0,2"]
["Baseline NIHSS Motor Right Leg"]
["     N",null,15,null,13,null,14,null,42]
["     Mean (SD)",null,0.5,"(0.8)",0.6,"(1.1)",1.6,"(1.6)",0.9,"(1.3)"]
["     Median",null,0,null,0,null,1,null,0]
["     Minimum, Maximum",null,"0,1",null,"0,1",null,"0,3",null,"0,2"]
["Baseline PHQ2"]
["     N",null,13,null,9,null,10,null,32]
["     Mean (SD)",null,1.2,"(1.7)",1.3,"(1.9)",0.8,"(1.1)",1.1,"(1.6)"]
["     Median",null,0,null,0,null,0,null,0]
["     Minimum, Maximum",null,"0,6",null,"0,5",null,"0,3",null,"0,6"]
["Baseline PHQ9"]
["     N",null,13,null,9,null,10,null,32]
["     Mean (SD)",null,2.4,"(6.0)",3,"(5.2)",2.3,"(5.6)",2.5,"(5.5)"]
["     Median",null,0,null,0,null,0,null,0]
["     Minimum, Maximum",null,"0,22",null,"0,13",null,"0,18",null,"0,22"]
["Note: Percentages are based on number of randomized participants."]
["*Participants may be categorized into more than one race."]
["PAS, NHISS, PHQ9: higher scores are worse; FOIS- lower scores are worse."]

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["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 3: Inclusion/Exclusion Criteria - Randomized Participants"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Overall     (N=42)"]
[null,"N","%","N","%","N","%","N","%"]
["Inclusion/Exclusion Criteria Failure",0,0,0,0,0,0,0,0]
["       Inclusion Criteria Failure",0,0,0,0,0,0,0,0]
["             <21 Years or >90 Years of Age",0,0,0,0,0,0,0,0]
["             No Unilateral Hemispheric Infarction",0,0,0,0,0,0,0,0]
["             No Stroke Onset within 25-144 Hours of Study Treatment",0,0,0,0,0,0,0,0]
["             PAS Score <4",0,0,0,0,0,0,0,0]
["        Exclusion Criteria Failure",0,0,0,0,0,0,0,0]
["             Previous History of Swallowing Difficulties",0,0,0,0,0,0,0,0]
["             Progressive Neurological Disorder",0,0,0,0,0,0,0,0]
["    Drowsiness or Marked Cognitive Impairment",0,0,0,0,0,0,0,0]
["    Language Comprehension Difficulties",0,0,0,0,0,0,0,0]
["    Ongoing Use of CNS-Active Medications",0,0,0,0,0,0,0,0]
["    Severe COPD",0,0,0,0,0,0,0,0]
["    Unable to Undergo MRI due to Claustrophobia",0,0,0,0,0,0,0,0]
["    Unable to Undergo MRI due to Implant",0,0,0,0,0,0,0,0]
["    Unable to Undergo MRI due to Clips",0,0,0,0,0,0,0,0]
["    Unable to Undergo MRI due to Metal",0,0,0,0,0,0,0,0]
["    Damaged Skin at Site of Stimulation",0,0,0,0,0,0,0,0]
["    History of Seizures",0,0,0,0,0,0,0,0]
["    Pregnancy or Positive Pregnancy Test",0,0,0,0,0,0,0,0]
["    Severe Congestive Heart Failure",0,0,0,0,0,0,0,0]
["    Terminal Cancer",0,0,0,0,0,0,0,0]
["    NIHSS Score >25",0,0,0,0,0,0,0,0]
["             Post-ischemic Hemorrhagic Transformations, PH Type 2",0,0,0,0,0,0,0,0]
["    Significant Fluctuations in Neurological Exam within Preceding 24 Hours",0,0,0,0,0,0,0,0]
["                 Candidate for Hemicraniectomy, Carotid Endarterectomy, or Other Interventional Procedures",0,0,0,0,0,0,0,0]
["                 Intubation ≥4 Days",0,0,0,0,0,0,0,0]
["    Increased Risk",0,0,0,0,0,0,0,0]
["Note: Percentages are based on number of randomized participants."]

{"sheet":"AE Summary","index":6,"n_rows":32,"n_cols":9,"rows_kept":32,"merged":[[0,0,0,8],[1,0,1,8],[3,0,3,2],[4,0,4,2],[6,0,6,9],[7,1,7,8],[8,1,8,2],[8,3,8,4],[8,5,8,6],[8,7,8,8],[30,0,30,5],[31,0,31,5]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.1: Treatment Emergent Adverse Event Summary through Day 5 or Discharge - Treated Participants"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Overall     (N=42)"]
[null,"N","%","N","%","N","%","N","%"]
["At Least One Adverse Event",6,40,2,15,4,29,12,29]
[]
["Maximum Severity Experienced",0,0,0,0,0,0,0,0]
["   Mild",3,20,1,8,4,29,8,19]
["   Moderate",1,7,1,8,0,0,2,5]
["   Severe",2,13,0,0,0,0,2,3]
["   Life Threatening/Disabling",0,0,0,0,0,0,0,0]
["   Fatal",0,0,0,0,0,0,0,0]
["       Related to Stroke",0,0,0,0,0,0,0,0]
["       Not Related to Stroke",0,0,0,0,0,0,0,0]
[]
["Maximum Relationship to Study Intervention",6,40,2,15,4,29,12,29]
["   Unrelated",5,83,2,100,4,100,11,92]
["   Unlikely",1,17,0,0,0,0,0,0]
["   Possible",0,0,0,0,0,0,1,8]
["   Probable",0,0,0,0,0,0,0,0]
["   Definite",0,0,0,0,0,0,0,0]
[]
["At Least One Serious Event",3,20,1,8,0,0,4,10]
["Note: Counts are participant-based."]
["Note: Percentages are based on number of treated participants."]
["Note: All serious and non-serious events through Day 5 or discharge are tabulated."]

{"sheet":"SAE Summary","index":7,"n_rows":30,"n_cols":9,"rows_kept":30,"merged":[[0,0,0,8],[1,0,1,8],[3,0,3,2],[4,0,4,2],[6,0,6,13],[7,1,7,8],[8,1,8,2],[8,3,8,4],[8,5,8,6],[8,7,8,8],[28,0,28,5],[29,0,29,5]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.2: Treatment Emergent Serious Adverse Event Summary through Study Completion - Treated Participants"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Overall     (N=42)"]
[null,"N","%","N","%","N","%","N","%"]
["At Least One Serious Adverse Event",4,27,1,8,2,14,7,17]
[null,0,0,0,0,0,0,0,0]
["Maximum Severity Experienced",0,0,0,0,0,0,0,0]
["   Mild",1,7,0,0,1,7,2,5]
["   Moderate",1,7,0,0,0,0,1,2]
["   Severe",1,7,0,0,0,0,1,2]
["   Life Threatening/Disabling",0,0,0,0,0,0,0,0]
["   Fatal",1,7,1,8,1,7,3,7]
["       Related to Stroke",1,100,1,100,1,100,3,100]
["       Not Related to Stroke",0,0,0,0,0,0,0,0]
[null,0,0,0,0,0,0,0,0]
["Maximum Relationship to Study Intervention",4,27,1,8,2,14,7,17]
["   Unrelated",3,75,1,100,2,100,6,86]
["   Unlikely",0,0,0,0,0,0,0,0]
["   Possible",1,25,0,0,0,0,1,14]
["   Probable",0,0,0,0,0,0,0,0]
["   Definite",0,0,0,0,0,0,0,0]
["Note: Counts are participant-based."]
["Note: Percentages are based on number of treated participants."]
["Note: All serious events through study completion are tabulated."]

{"sheet":"AETerms Including Deterioration","index":8,"n_rows":45,"n_cols":9,"rows_kept":45,"merged":[[0,0,0,8],[0,9,0,17],[1,0,1,8],[1,9,1,17],[3,0,3,2],[3,9,3,11],[4,0,4,2],[4,9,4,11],[6,0,6,9],[8,1,8,2],[8,3,8,4],[8,5,8,6],[8,7,8,8]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.3: Treatment Emergent Adverse Events through Day 5 or Discharge - Treated Participants"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Overall  (N=42)"]
[null,"N","%","N","%","N","%","N              %","%"]
["At Least One Adverse Event",6,40,2,15,4,29,12,29]
[null,0,0,0,0,0,0,0,0]
["Seizures During Simulation",0,0,0,0,0,0,0,0]
["Neurological Deterioration",0,0,0,0,0,0,0,0]
["Limb Deterioration",0,0,0,0,0,0,0,0]
["Swallowing Deterioration",0,0,0,0,0,0,0,0]
["Death",0,0,0,0,0,0,0,0]
["Other",6,40,2,15,4,29,12,29]
["   Cardiac",2,13,0,0,0,0,2,5]
["        Atrial Fibrilation w rapid ventricular rate",1,50,0,0,0,0,1,50]
["        Episodic tachycardia",1,50,0,0,0,0,1,50]
["   Endocrine",0,0,0,0,1,7,1,2]
["       Hyperglycemia",0,0,0,0,1,100,1,100]
["   Gastrointestinal",0,0,1,8,0,0,1,2]
["       Diarrhea",0,0,1,100,0,0,1,100]
["   Immune",1,7,0,0,2,14,3,7]
["       Fever",1,100,0,0,2,100,3,100]
["   Infections and Infestations",1,7,0,0,0,0,1,2]
["      Infection",1,100,0,0,0,0,1,100]
["   Metabolism and Nutrition",1,7,0,0,0,0,1,2]
["       Metabolism and nutrition disorders",1,100,0,0,0,0,1,100]
["   Musculoskeletal",0,0,1,7,0,0,1,2]
["       Fall",0,0,1,100,0,0,1,100]
["   Psychiatric",1,7,0,0,1,7,1,2]
["       Depression",1,100,0,0,1,100,1,100]
["   Respiratory",1,7,1,7,0,0,2,5]
["       Pneumonia",0,0,1,100,0,0,1,50]
["       Respiratory distress",1,100,0,0,0,0,1,50]
["       Severe sepsis",0,0,0,0,0,0,0,0]
["   Urinary",0,0,1,7,0,0,1,2]
["       Urinary tract infection",0,0,1,100,0,0,1,100]
["  Vascular",0,0,0,0,2,14,2,5]
["       Deep vein thrombosis",0,0,0,0,1,50,1,50]
["       Pulmonary Embolism",0,0,0,0,0,0,0,0]
["       Thromboembolic event",0,0,0,0,1,50,1,50]

{"sheet":"SAETerms","index":9,"n_rows":29,"n_cols":9,"rows_kept":29,"merged":[[0,0,0,8],[0,9,0,17],[1,0,1,8],[1,9,1,17],[3,0,3,2],[3,9,3,11],[4,0,4,2],[4,9,4,11],[6,0,6,13],[8,1,8,2],[8,3,8,4],[8,5,8,6],[8,7,8,8],[27,0,27,5],[28,0,28,5]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.4: Treatment Emergent Serious Adverse Events through Study Completion - Treated Participants"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Overall     (N=42)"]
[null,"N","%","N","%","N","%","N","%"]
["At Least One Serious Adverse Event",4,27,1,8,2,14,7,17]
[null,0,0,0,0,0,0,0,0]
["Seizures During Simulation",0,0,0,0,0,0,0,0]
["Death",1,7,1,8,1,7,3,7]
["Other",3,20,1,8,1,7,5,12]
["   Cardiac",1,7,0,0,0,0,1,2]
["        Atrial Fibrilation w rapid ventricular rate",1,100,0,0,0,0,1,100]
["   Infections and Infestations",1,7,0,0,0,0,1,2]
["       Infection",1,100,0,0,0,0,1,100]
["   Respiratory",1,7,0,0,1,7,2,5]
["       Pneumonia",0,0,0,0,1,100,1,50]
["       Respiratory distress",1,100,0,0,0,0,1,50]
["       Severe sepsis",0,0,0,0,0,0,0,0]
["  Vascular",0,0,1,8,0,0,1,2]
["       Deep vein thrombosis",0,0,1,100,0,0,1,100]
["       Pulmonary Embolism",0,0,0,0,0,0,0,0]
["       Thromboembolic event",0,0,0,0,0,0,0,0]
["Note: Percentages are based on number of treated participants."]
["Note: All serious events through study completion are tabulated."]

{"sheet":"AE SummarySeverity","index":10,"n_rows":47,"n_cols":25,"rows_kept":47,"merged":[[0,0,0,8],[1,0,1,12],[3,0,3,2],[4,0,4,2],[6,0,6,10],[8,0,9,0],[8,1,9,6],[8,7,9,12],[8,13,9,18],[8,19,9,24],[10,0,11,0],[10,1,10,2],[10,3,10,4],[10,5,10,6],[10,7,10,8],[10,9,10,10],[10,11,10,12],[10,13,10,14],[10,15,10,16],[10,17,10,18],[10,19,10,20],[10,21,10,22],[10,23,10,24],[44,0,44,17],[45,0,45,5],[46,0,46,11]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.5: Treatment Emergent Adverse Events through Day 5 or Discharge by Severity - Treated Participants"]
[]
[null,"Mild",{"$nulls":5},"Moderate",{"$nulls":5},"Severe",{"$nulls":5},"Life-Threatening/Disabling/Death"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)"]
[null,"N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%"]
["At Least One Adverse Event",4,27,3,23,5,36,1,7,1,8,0,0,2,17,0,0,0,0,0,0,0,0,0,0]
[null,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Seizures During Simulation",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Death",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Other",4,27,3,23,5,36,1,7,0,0,1,7,2,17,0,0,0,0,0,0,0,0,0,0]
["   Cardiac",2,13,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["        Atrial Fibrilation and Heart Failure",1,50,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["        Episodic tachycardia",1,50,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Endocrine",0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Hyperglycemia",0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Gastrointestinal",0,0,1,8,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Diarrhea",0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Immune",1,8,0,0,2,14,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Fever",1,100,0,0,2,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Infections and Infestations",0,0,0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["      Infection",0,0,0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Metabolism and Nutrition",1,8,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Metabolism and nutrition disorders",1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Musculoskeletal",0,0,1,8,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Fall",0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Psychiatric",0,0,0,0,0,0,0,0,0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0]
["       Depression",0,0,0,0,0,0,0,0,0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0]
["   Respiratory",0,0,0,0,0,0,0,0,1,8,0,0,1,7,0,0,0,0,0,0,0,0,0,0]
["       Pneumonia",0,0,0,0,0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Respiratory distress",0,0,0,0,0,0,0,0,0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0]
["       Severe sepsis",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Urinary",0,0,1,8,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       urinary tract infection",0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Vascular",0,0,0,0,2,14,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Deep vein thrombosis",0,0,0,0,1,50,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Pulmonary Embolism",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Thromboembolic event",0,0,0,0,1,50,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Note: Counts are Participant-based.  Participants are categorized under the maximum severity experienced within each adverse event."]
["Note: Percentages are based on number of treated participants."]
["Note: All serious and non-serious events through Day 5 or discharge are tabulated."]

{"sheet":"SAE SummarySeverity","index":11,"n_rows":32,"n_cols":25,"rows_kept":32,"merged":[[0,0,0,8],[1,0,1,12],[3,0,3,2],[4,0,4,2],[6,0,6,13],[8,0,9,0],[8,1,9,6],[8,7,9,12],[8,13,9,18],[8,19,9,24],[10,0,11,0],[10,1,10,2],[10,3,10,4],[10,5,10,6],[10,7,10,8],[10,9,10,10],[10,11,10,12],[10,13,10,14],[10,15,10,16],[10,17,10,18],[10,19,10,20],[10,21,10,22],[10,23,10,24],[29,0,29,17],[30,0,30,5],[31,0,31,5]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.6: Treatment Emergent Serious Adverse Events through Study Completion by Severity - Treated Participants"]
[]
[null,"Mild",{"$nulls":5},"Moderate",{"$nulls":5},"Severe",{"$nulls":5},"Life-Threatening/Disabling/Death"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)"]
[null,"N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%"]
["At Least One Serious Adverse Event",1,7,0,0,1,7,1,7,1,8,0,0,1,7,0,0,0,0,1,7,1,8,1,7]
[null,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Seizures During Simulation",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Death",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,1,8,1,7]
["Other",1,7,0,0,1,7,1,8,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Cardiac",1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["        Atrial Fibrilation and Heart Failure",1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Infections and Infestations",0,0,0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Infection",0,0,0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Respiratory",0,0,0,0,0,0,0,0,1,8,0,0,1,7,0,0,0,0,1,7,0,0,0,0]
["       Pneumonia",0,0,0,0,0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Respiratory distress",0,0,0,0,0,0,0,0,0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0]
["       Severe sepsis",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,1,100,0,0,0,0]
["  Vascular",0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Deep vein thrombosis",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Pulmonary Embolism",0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Thromboembolic event",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Note: Counts are Participant-based.  Participants are categorized under the maximum severity experienced within each adverse event."]
["Note: Percentages are based on number of treated participants."]
["Note: All serious events through study completion are tabulated."]

{"sheet":"AESummaryRelat","index":12,"n_rows":46,"n_cols":25,"rows_kept":46,"merged":[[0,0,0,14],[1,0,1,18],[3,0,3,2],[4,0,4,2],[6,0,6,24],[8,0,9,0],[8,1,9,6],[8,7,9,12],[8,13,9,18],[8,19,9,24],[10,0,11,0],[10,1,10,2],[10,3,10,4],[10,5,10,6],[10,7,10,8],[10,9,10,10],[10,11,10,12],[10,13,10,14],[10,15,10,16],[10,17,10,18],[10,19,10,20],[10,21,10,22],[10,23,10,24],[44,0,44,23],[45,0,45,5]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.7: Treatment Emergent Adverse Events through Day 5 or Discharge by Relationship to Intervention - Treated Participants"]
[]
[null,"Unrelated",{"$nulls":5},"Remote/Unlikely",{"$nulls":5},"Possible",{"$nulls":5},"Probably/Definite"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)"]
[null,"N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%"]
["At Least One Adverse Event",6,40,4,31,5,36,0,0,0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0]
[null,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Seizures During Simulation",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Death",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Other",6,40,4,31,5,36,0,0,0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0]
["   Cardiac",2,13,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["        Atrial Fibrilation and Heart Failure",1,50,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["        Episodic tachycardia",1,50,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Endocrine",0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Hyperglycemia",0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Gastrointestinal",0,0,1,8,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Diarrhea",0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Immune",1,7,0,0,2,14,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Fever",1,100,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Infections and Infestations",1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["      Infection",1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Metabolism and Nutrition",1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Metabolism and nutrition disorders",1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Musculoskeletal",0,0,1,8,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Fall",0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Psychiatric",1,7,0,0,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Depression",1,100,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Respiratory",0,0,1,8,0,0,0,0,0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0]
["       Pneumonia",0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Respiratory distress",0,0,0,0,0,0,0,0,0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0]
["       Severe sepsis",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Urinary",0,0,1,8,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       urinary tract infection",0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Vascular",0,0,0,0,2,14,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Deep vein thrombosis",0,0,0,0,1,50,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Pulmonary Embolism",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Thromboembolic event",0,0,0,0,1,50,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Note: Counts are Participant-based.  Participants are categorized under the maximum relationship experienced within each adverse event."]
["Note: Percentages are based on number of treated participants."]

{"sheet":"SAE SummaryRelat","index":13,"n_rows":32,"n_cols":25,"rows_kept":32,"merged":[[0,0,0,14],[1,0,1,18],[3,0,3,2],[4,0,4,2],[6,0,6,23],[8,0,9,0],[8,1,9,6],[8,7,9,12],[8,13,9,18],[8,19,9,24],[10,0,11,0],[10,1,10,2],[10,3,10,4],[10,5,10,6],[10,7,10,8],[10,9,10,10],[10,11,10,12],[10,13,10,14],[10,15,10,16],[10,17,10,18],[10,19,10,20],[10,21,10,22],[10,23,10,24],[29,0,29,23],[30,0,30,5],[31,0,31,5]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.8: Treatment Emergent Serious Adverse Events through Study Completion by Relationship to Intervention - Treated Participants"]
[]
[null,"Unrelated",{"$nulls":5},"Remote/Unlikely",{"$nulls":5},"Possible",{"$nulls":5},"Probably/Definite"]
[]
[null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)"]
[null,"N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%","N","%"]
["At Least One Adverse Event",3,21,2,15,2,14,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
[null,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Seizures During Simulation",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Death",0,0,1,8,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Other",3,21,1,8,1,7,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Cardiac",1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["        Atrial Fibrilation and Heart Failure",1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Infections and Infestations",1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Infection",1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["   Respiratory",1,7,1,8,0,0,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Pneumonia",0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Respiratory distress",0,0,0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Severe sepsis",1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["  Vascular",0,0,0,0,1,7,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Deep vein thrombosis",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Pulmonary Embolism",0,0,0,0,1,100,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["       Thromboembolic event",0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0]
["Note: Counts are Participant-based.  Participants are categorized under the maximum severity experienced within each adverse event."]
["Note: Percentages are based on number of treated participants."]
["Note: All serious events through study completion are tabulated."]

{"sheet":"SAEList","index":14,"n_rows":17,"n_cols":13,"rows_kept":17,"merged":[[0,0,0,8],[1,0,1,12],[3,0,3,2],[4,0,4,2],[6,0,6,12]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.9: Listing of Serious Adverse Events through Study Completion - Treated Participants"]
[]
["Participant ID","Treatment Group","Age ","Gender","Serious Adverse Event","Treatment Start Date","Treatment Stop Date","SAE Onset Date ","SAE Stop Date","Severity","Relationship to Treatment","Outcome","Action Taken"]
["xxx",3,"x","Female","Urosepsis","2014-06-11","2014-06-16","2014-06-18","2014-06-18","Fatal","Unrelated","Death","None"]
["xxx",2,"x","Male","Pneumonia","2014-09-08","2014-09-09","2014-09-09",null,"Moderate","Unrelated","Continuing","Med Change"]
["xxx",2,"x","Male","GI Bleed and Epistaxis","2014-09-08","2014-09-12","2014-09-25","2014-09-25","Fatal","Unrelated","Death","None"]
["xxx",1,"x","Female","Atrial Fibrillation","2015-05-09","2015-05-11","2015-05-11","2015-05-13","Mild","Unrelated","Resolved","Med Change"]
["xxx",1,"x","Female","Severe sepsis","2016-03-15","2016-03-18","2016-04-22","2016-04-22","Fatal","Unrelated","Death","None"]
["xxx",3,"x","Male","Pulmonary Embolism","2016-09-30","2016-10-04","2016-10-07",null,"Mild","Unrelated","Continuing","Med Change"]
["xxx",1,"x","Male","Urinary tract infection.","2018-07-31","08/04/0218","2018-08-04","2018-08-06","Moderate","Unrelated","Resolved","Med Change"]
["xxx",1,"x","Male","Respiratory Distress","2018-10-31","2018-11-02","2018-11-03","2018-11-04","Severe","Possibly related","Resolved","Med Change/Intubation"]

{"sheet":"Death-Closed","index":15,"n_rows":12,"n_cols":10,"rows_kept":12,"merged":[[0,0,0,8],[1,0,1,12],[3,0,3,2],[4,0,4,2],[6,0,6,9],[17,2,17,5],[18,2,18,4],[19,2,19,4],[20,2,20,5],[21,2,21,4],[22,2,22,4]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 4.10: Listing of Deaths through Study Completion - Treated Participants"]
[]
["Site","Participant ID","Gender","Age","Treatment Group","Date Enrolled","Date of Death ","Treatment Start Date","Cause of Death","Related to Treatment"]
[1,"xxx","Female","x",3,"2014-06-11","2014-06-18","2014-06-11","Urosepsis","Unrelated"]
[2,"xxx","Male","x",2,"2014-09-08","2014-09-25","2014-09-08","GI Bleed and Epistaxis","Unrelated"]
[3,"xxx","Female","x",1,"2016-03-14","2016-04-10","2016-03-15","Severe sepsis","Unrelated"]

{"sheet":"PAS and others","index":16,"n_rows":27,"n_cols":13,"rows_kept":27,"merged":[[0,0,0,8],[1,0,1,12],[3,0,3,2],[4,0,4,2],[6,0,6,9],[8,0,8,1],[8,2,8,3],[8,4,8,5],[8,6,8,7],[8,8,8,9],[8,10,8,11],[8,12,8,13],[9,2,9,3],[9,4,9,5],[9,6,9,7],[9,8,9,9],[9,10,9,11],[9,12,9,13],[10,0,10,1],[10,2,10,3],[10,4,10,5],[10,6,10,7],[10,8,10,9],[10,10,10,11],[10,12,10,13],[11,0,11,1],[11,8,11,9],[11,10,11,11],[11,12,11,13],[12,0,12,1],[12,2,12,3],[12,4,12,5],[12,6,12,7],[12,8,12,9],[12,10,12,11],[12,12,12,13],[13,0,13,1],[13,2,13,3],[13,4,13,5],[13,6,13,7],[13,8,13,9],[13,10,13,11],[13,12,13,13],[14,8,14,9],[14,10,14,11],[14,12,14,13],[15,0,15,1],[15,2,15,3],[15,4,15,5],[15,6,15,7],[15,8,15,9],[15,10,15,11],[15,12,15,13],[16,0,16,1],[16,8,16,9],[16,10,16,11],[16,12,16,13],[17,0,17,1],[17,2,17,3],[17,4,17,5],[17,6,17,7],[17,8,17,9],[17,10,17,11],[17,12,17,13],[18,0,18,1],[18,2,18,3],[18,4,18,5],[18,6,18,7],[18,8,18,9],[18,10,18,11],[18,12,18,13],[19,2,19,3],[19,4,19,5],[19,6,19,7],[19,8,19,9],[19,10,19,11],[19,12,19,13],[20,0,20,1],[20,2,20,3],[20,4,20,5],[20,6,20,7],[20,8,20,9],[20,10,20,11],[20,12,20,13],[21,0,21,1],[21,8,21,9],[21,10,21,11],[21,12,21,13],[22,0,22,1],[22,2,22,3],[22,4,22,5],[22,6,22,7],[22,8,22,9],[22,10,22,11],[22,12,22,13],[23,0,23,1],[23,2,23,3],[23,4,23,5],[23,6,23,7],[23,8,23,9],[23,10,23,11],[23,12,23,13],[24,0,24,11],[27,0,27,11]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 5.1: Average Penetration and Aspiration Scale (PAS) Scores - Intent-to-Treat Analysis Set"]
[]
["Characteristic",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"P-Value T1 vs.T2*",null,"P-Value T1 vs. T3*",null,"P-Value T2 vs. T3*"]
["Baseline PAS",{"$nulls":7},0.98,null,0.99,null,0.99]
["     N ",null,15,null,13,null,14]
["     Mean (SD)",null,4,"(1.6)",4.1,"(1.0)",4.1,"(1.1)"]
["     Median",null,3.7,null,4.3,null,4.2]
["     Minimum, Maximum",null,"2.4,8.0",null,"1.6,5.5",null,"2.4,6.4"]
["Exit PAS "]
["     N",null,15,null,13,null,14]
["     Mean (SD)",null,3.2,"(1.6)",3.3,"(1.4)",3.7,"(1.5)"]
["     Median",null,3,null,3.2,null,3.8]
["     Minimum, Maximum",null,"1.0,5.4",null,"1.2,7.3",null,"1.2,6.8"]
["Change from Baseline to Exit PAS",{"$nulls":7},0.98,null,0.65,null,0.79]
["     N",null,15,null,13,null,14]
["     Mean (SD)",null,-0.8,"(1.6)",-0.8,"(1.5)",-0.4,"(1.2)"]
["     Median",null,-0.8,null,-1,null,-0.6]
["     Minimum, Maximum",null,"-4.3,1.3",null,"-3.7,2.5",null,"-2.2,1.6"]
["*Baseline p-value based on one-way analysis of variance; change from baseline p-value based on analysis of covariance"]
[" adjusting for baseline PAS."]
["Higher scores are worse."]

{"sheet":"FOIS","index":17,"n_rows":47,"n_cols":13,"rows_kept":47,"merged":[[0,0,0,8],[1,0,1,12],[3,0,3,2],[4,0,4,2],[6,0,6,9],[8,0,8,1],[8,2,8,3],[8,4,8,5],[8,6,8,7],[8,8,8,9],[8,10,8,11],[8,12,8,13],[9,2,9,3],[9,4,9,5],[9,6,9,7],[9,8,9,9],[9,10,9,11],[9,12,9,13],[10,0,10,1],[10,2,10,3],[10,4,10,5],[10,6,10,7],[10,8,10,9],[10,10,10,11],[10,12,10,13],[11,0,11,1],[11,8,11,9],[11,10,11,11],[11,12,11,13],[12,0,12,1],[12,2,12,3],[12,4,12,5],[12,6,12,7],[12,8,12,9],[12,10,12,11],[12,12,12,13],[13,0,13,1],[13,2,13,3],[13,4,13,5],[13,6,13,7],[13,8,13,9],[13,10,13,11],[13,12,13,13],[14,2,14,3],[14,4,14,5],[14,6,14,7],[14,8,14,9],[14,10,14,11],[14,12,14,13],[15,0,15,1],[15,2,15,3],[15,4,15,5],[15,6,15,7],[15,8,15,9],[15,10,15,11],[15,12,15,13],[16,0,16,1],[16,8,16,9],[16,10,16,11],[16,12,16,13],[17,0,17,1],[17,2,17,3],[17,4,17,5],[17,6,17,7],[17,8,17,9],[17,10,17,11],[17,12,17,13],[18,0,18,1],[18,2,18,3],[18,4,18,5],[18,6,18,7],[18,8,18,9],[18,10,18,11],[18,12,18,13],[19,2,19,3],[19,4,19,5],[19,6,19,7],[19,8,19,9],[19,10,19,11],[19,12,19,13],[20,0,20,1],[20,2,20,3],[20,4,20,5],[20,6,20,7],[20,8,20,9],[20,10,20,11],[20,12,20,13],[21,0,21,1],[21,8,21,9],[21,10,21,11],[21,12,21,13],[22,0,22,1],[22,2,22,3],[22,4,22,5],[22,6,22,7],[22,8,22,9],[22,10,22,11],[22,12,22,13],[23,0,23,1],[23,2,23,3],[23,4,23,5],[23,6,23,7],[23,8,23,9],[23,10,23,11],[23,12,23,13],[24,2,24,3],[24,4,24,5],[24,6,24,7],[24,8,24,9],[24,10,24,11],[24,12,24,13],[25,0,25,1],[25,2,25,3],[25,4,25,5],[25,6,25,7],[25,8,25,9],[25,10,25,11],[25,12,25,13],[26,0,26,1],[26,8,26,9],[26,10,26,11],[26,12,26,13],[27,0,27,1],[27,2,27,3],[27,4,27,5],[27,6,27,7],[27,8,27,9],[27,10,27,11],[27,12,27,13],[28,0,28,1],[28,2,28,3],[28,4,28,5],[28,6,28,7],[28,8,28,9],[28,10,28,11],[28,12,28,13],[29,2,29,3],[29,4,29,5],[29,6,29,7],[29,8,29,9],[29,10,29,11],[29,12,29,13],[30,0,30,1],[30,2,30,3],[30,4,30,5],[30,6,30,7],[30,8,30,9],[30,10,30,11],[30,12,30,13],[31,0,31,1],[31,8,31,9],[31,10,31,11],[31,12,31,13],[32,0,32,1],[32,2,32,3],[32,4,32,5],[32,6,32,7],[32,8,32,9],[32,10,32,11],[32,12,32,13],[33,0,33,1],[33,2,33,3],[33,4,33,5],[33,6,33,7],[33,8,33,9],[33,10,33,11],[33,12,33,13],[34,2,34,3],[34,4,34,5],[34,6,34,7],[34,8,34,9],[34,10,34,11],[34,12,34,13],[35,0,35,1],[35,2,35,3],[35,4,35,5],[35,6,35,7],[35,8,35,9],[35,10,35,11],[35,12,35,13],[36,0,36,1],[36,8,36,9],[36,10,36,11],[36,12,36,13],[37,0,37,1],[37,2,37,3],[37,4,37,5],[37,6,37,7],[37,8,37,9],[37,10,37,11],[37,12,37,13],[38,0,38,1],[38,2,38,3],[38,4,38,5],[38,6,38,7],[38,8,38,9],[38,10,38,11],[38,12,38,13],[39,2,39,3],[39,4,39,5],[39,6,39,7],[39,8,39,9],[39,10,39,11],[39,12,39,13],[40,0,40,1],[40,2,40,3],[40,4,40,5],[40,6,40,7],[40,8,40,9],[40,10,40,11],[40,12,40,13],[41,0,41,1],[41,8,41,9],[41,10,41,11],[41,12,41,13],[42,0,42,1],[42,2,42,3],[42,4,42,5],[42,6,42,7],[42,8,42,9],[42,10,42,11],[42,12,42,13],[43,0,43,1],[43,2,43,3],[43,4,43,5],[43,6,43,7],[43,8,43,9],[43,10,43,11],[43,12,43,13],[44,0,44,11]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 5.5: Functional Oral Intake Scale (FOIS) Scores - Intent-to-Treat Analysis Set"]
[]
["Characteristic",null,"Treatment 1 (N=13)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"P-Value T1 vs.T2*",null,"P-Value T1 vs. T3*",null,"P-Value T2 vs. T3*"]
["Baseline FOIS",{"$nulls":7},0.99,null,0.58,null,0.64]
["     N ",null,15,null,13,null,14]
["     Mean (SD)",null,2.7,"(1.3)",2.8,"(1.5)",3.3,"(1.6)"]
["     Median",null,2,null,2,null,3]
["     Minimum, Maximum",null,"1,6",null,"1,6",null,"1,5"]
["Day 3 FOIS"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,3.1,"(1.6)",3.5,"(1.9)",4.1,"(1.6)"]
["     Median",null,3.5,null,4,null,4]
["     Minimum, Maximum",null,"1,5",null,"1,7",null,"2,7"]
["Change from Baseline to Day 3 FOIS",{"$nulls":7},0.76,null,0.62,null,0.98]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0.5,"(1.0)",0.8,"(1.2)",0.8,"(0.7)"]
["     Median",null,0,null,1,null,1]
["     Minimum, Maximum",null,"-1,3",null,"-1,4",null,"0,2"]
["Day 5 FOIS"]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,{"v":3,"d":"3.0"},"(1.3)",3.2,"(2.1)",4.3,"(1.8)"]
["     Median",null,4,null,3,null,4]
["     Minimum, Maximum",null,"1,4",null,"1,6",null,"2,7"]
["Change from Baseline to Day 5 FOIS",{"$nulls":7},{"v":0.9,"d":"0.90"},null,0.48,null,{"v":0.8,"d":"0.80"}]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,0.9,"(1.3)",1.2,"(1.6)",1.6,"(0.8)"]
["     Median",null,0.5,null,2,null,1]
["     Minimum, Maximum",null," -1,3",null,"0,4",null,"0,3"]
["Day 30 FOIS"]
["     N",null,14,null,12,null,12]
["     Mean (SD)",null,4.9,"(2.2)",5.4,"(0.9)",6.3,"(1.0)"]
["     Median",null,5.5,null,5,null,7]
["     Minimum, Maximum",null,"1,7",null,"4,7",null,"4,7"]
["Change from Baseline to Day 30 FOIS",{"$nulls":7},0.71,null,0.12,null,0.46]
["     N",null,14,null,12,null,12]
["     Mean (SD)",null,2.1,"(1.7)",2.5,"(1.7)",2.9,"(1.2)"]
["     Median",null,2,null,2.5,null,3]
["     Minimum, Maximum",null,"0,5",null,"0,6",null,"1,5"]
["*Baseline p-value based on one-way analysis of variance; change from baseline p-value based on analysis of covariance"]
[" adjusting for baseline Fois."]
["Lower scores are worse."]

{"sheet":"NIHSS","index":18,"n_rows":57,"n_cols":13,"rows_kept":57,"merged":[[0,0,0,8],[1,0,1,12],[3,0,3,2],[4,0,4,2],[6,0,6,9],[8,0,8,1],[8,2,8,3],[8,4,8,5],[8,6,8,7],[8,8,8,9],[8,10,8,11],[8,12,8,13],[9,2,9,3],[9,4,9,5],[9,6,9,7],[9,8,9,9],[9,10,9,11],[9,12,9,13],[10,0,10,1],[10,2,10,3],[10,4,10,5],[10,6,10,7],[10,8,10,9],[10,10,10,11],[10,12,10,13],[11,0,11,1],[11,8,11,9],[11,10,11,11],[11,12,11,13],[12,0,12,1],[12,2,12,3],[12,4,12,5],[12,6,12,7],[12,8,12,9],[12,10,12,11],[12,12,12,13],[13,0,13,1],[13,2,13,3],[13,4,13,5],[13,6,13,7],[13,8,13,9],[13,10,13,11],[13,12,13,13],[14,2,14,3],[14,4,14,5],[14,6,14,7],[14,8,14,9],[14,10,14,11],[14,12,14,13],[15,0,15,1],[15,2,15,3],[15,4,15,5],[15,6,15,7],[15,8,15,9],[15,10,15,11],[15,12,15,13],[16,0,16,1],[16,8,16,9],[16,10,16,11],[16,12,16,13],[17,0,17,1],[17,2,17,3],[17,4,17,5],[17,6,17,7],[17,8,17,9],[17,10,17,11],[17,12,17,13],[18,0,18,1],[18,2,18,3],[18,4,18,5],[18,6,18,7],[18,8,18,9],[18,10,18,11],[18,12,18,13],[19,2,19,3],[19,4,19,5],[19,6,19,7],[19,8,19,9],[19,10,19,11],[19,12,19,13],[20,0,20,1],[20,2,20,3],[20,4,20,5],[20,6,20,7],[20,8,20,9],[20,10,20,11],[20,12,20,13],[21,0,21,1],[21,8,21,9],[21,10,21,11],[21,12,21,13],[22,0,22,1],[22,2,22,3],[22,4,22,5],[22,6,22,7],[22,8,22,9],[22,10,22,11],[22,12,22,13],[23,0,23,1],[23,2,23,3],[23,4,23,5],[23,6,23,7],[23,8,23,9],[23,10,23,11],[23,12,23,13],[24,2,24,3],[24,4,24,5],[24,6,24,7],[24,8,24,9],[24,10,24,11],[24,12,24,13],[25,0,25,1],[25,2,25,3],[25,4,25,5],[25,6,25,7],[25,8,25,9],[25,10,25,11],[25,12,25,13],[26,0,26,1],[26,8,26,9],[26,10,26,11],[26,12,26,13],[27,0,27,1],[27,2,27,3],[27,4,27,5],[27,6,27,7],[27,8,27,9],[27,10,27,11],[27,12,27,13],[28,0,28,1],[28,2,28,3],[28,4,28,5],[28,6,28,7],[28,8,28,9],[28,10,28,11],[28,12,28,13],[29,2,29,3],[29,4,29,5],[29,6,29,7],[29,8,29,9],[29,10,29,11],[29,12,29,13],[30,0,30,1],[30,2,30,3],[30,4,30,5],[30,6,30,7],[30,8,30,9],[30,10,30,11],[30,12,30,13],[31,0,31,1],[31,8,31,9],[31,10,31,11],[31,12,31,13],[32,0,32,1],[32,2,32,3],[32,4,32,5],[32,6,32,7],[32,8,32,9],[32,10,32,11],[32,12,32,13],[33,0,33,1],[33,2,33,3],[33,4,33,5],[33,6,33,7],[33,8,33,9],[33,10,33,11],[33,12,33,13],[34,2,34,3],[34,4,34,5],[34,6,34,7],[34,8,34,9],[34,10,34,11],[34,12,34,13],[35,0,35,1],[35,2,35,3],[35,4,35,5],[35,6,35,7],[35,8,35,9],[35,10,35,11],[35,12,35,13],[36,0,36,1],[36,8,36,9],[36,10,36,11],[36,12,36,13],[37,0,37,1],[37,2,37,3],[37,4,37,5],[37,6,37,7],[37,8,37,9],[37,10,37,11],[37,12,37,13],[38,0,38,1],[38,2,38,3],[38,4,38,5],[38,6,38,7],[38,8,38,9],[38,10,38,11],[38,12,38,13],[39,2,39,3],[39,4,39,5],[39,6,39,7],[39,8,39,9],[39,10,39,11],[39,12,39,13],[40,0,40,1],[40,2,40,3],[40,4,40,5],[40,6,40,7],[40,8,40,9],[40,10,40,11],[40,12,40,13],[41,0,41,1],[41,8,41,9],[41,10,41,11],[41,12,41,13],[42,0,42,1],[42,2,42,3],[42,4,42,5],[42,6,42,7],[42,8,42,9],[42,10,42,11],[42,12,42,13],[43,0,43,1],[43,2,43,3],[43,4,43,5],[43,6,43,7],[43,8,43,9],[43,10,43,11],[43,12,43,13],[44,2,44,3],[44,4,44,5],[44,6,44,7],[44,8,44,9],[44,10,44,11],[44,12,44,13],[45,0,45,1],[45,2,45,3],[45,4,45,5],[45,6,45,7],[45,8,45,9],[45,10,45,11],[45,12,45,13],[46,0,46,1],[46,8,46,9],[46,10,46,11],[46,12,46,13],[47,0,47,1],[47,2,47,3],[47,4,47,5],[47,6,47,7],[47,8,47,9],[47,10,47,11],[47,12,47,13],[48,0,48,1],[48,2,48,3],[48,4,48,5],[48,6,48,7],[48,8,48,9],[48,10,48,11],[48,12,48,13],[49,2,49,3],[49,4,49,5],[49,6,49,7],[49,8,49,9],[49,10,49,11],[49,12,49,13],[50,0,50,1],[50,2,50,3],[50,4,50,5],[50,6,50,7],[50,8,50,9],[50,10,50,11],[50,12,50,13],[51,0,51,1],[51,8,51,9],[51,10,51,11],[51,12,51,13],[52,0,52,1],[52,2,52,3],[52,4,52,5],[52,6,52,7],[52,8,52,9],[52,10,52,11],[52,12,52,13],[53,0,53,1],[53,2,53,3],[53,4,53,5],[53,6,53,7],[53,8,53,9],[53,10,53,11],[53,12,53,13],[54,0,54,11]],"flags":["formulas_cached_only"]}
["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 5.6: Functional Oral Intake Scale (NIHSS) Scores - Intent-to-Treat Analysis Set"]
[]
["Characteristic",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"P-Value T1 vs.T2*",null,"P-Value T1 vs. T3*",null,"P-Value T2 vs. T3*"]
["Baseline NIHSS",{"$nulls":7},0.99,null,0.75,null,0.75]
["     N ",null,15,null,13,null,14]
["     Mean (SD)",null,11.1,"(5.1)",11,"(6.5)",12.6,"(5.1)"]
["     Median",null,12,null,8,null,11.5]
["     Minimum, Maximum",null,"3,20",null,"3.5,24",null,"3,21"]
["Day 2 NIHSS"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,10.9,"(5.8)",11.5,"(5.5)",12.6,"(4.9)"]
["     Median",null,12.5,null,12,null,11.5]
["     Minimum, Maximum",null,"2,20",null,"4,21",null,"5,20"]
["Change from Baseline to Day 2 NIHSS",{"$nulls":7},0.84,null,0.89,null,0.99]
["     N",null,14,null,13,null,13]
["     Mean (SD)",null,-0.1,"(2.6)",0.4,"(3.9)",0.1,"(1.0)"]
["     Median",null,-0.8,null,0,null,-0.5]
["     Minimum, Maximum",null,"-3,7.5",null,"-4,9",null,"-1,2"]
["Day 3 NIHSS"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,10.9,"(5.8)",11.5,"(5.5)",12.6,"(4.9)"]
["     Median",null,12.5,null,12,null,11.5]
["     Minimum, Maximum",null,"2,20",null,"4,21",null,"5,20"]
["Change from Baseline to Day 3 NIHSS",{"$nulls":7},0.91,null,0.93,null,0.99]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,-0.4,"(2.3)",0,"(3.8)",-0.4,"(1.1)"]
["     Median",null,"-0.3",null,0,null,-1]
["     Minimum, Maximum",null,"-4,4.5",null,"-7,8",null,"-2,2"]
["Day 4 NIHSS"]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,11.3,"(5.5)",10.9,"(6.2)",12.6,"(5.1)"]
["     Median",null,12,null,10.5,null,15]
["     Minimum, Maximum",null,"2,20",null,"4,20",null,"6,20"]
["Change from Baseline to Day 4 NIHSS",{"$nulls":7},0.63,null,0.99,null,0.71]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,0,"(2.9)",-1.2,"(3.7)",-0.4,"(1.4)"]
["     Median",null,-0.5,null,-1.8,null,-1]
["     Minimum, Maximum",null,"-3,6.5",null,"-5,7",null,"-2,3"]
["Day 5 NIHSS"]
["     N",null,6,null,6,null,10]
["     Mean (SD)",null,10.8,"(6.2)",12.3,"(7.4)",11.8,"(6.0)"]
["     Median",null,10.5,null,15.3,null,11.5]
["     Minimum, Maximum",null,"2.5,19",null,"3,20",null,"4.5,20.5"]
["Change from Baseline to Day 5 NIHSS",{"$nulls":7},0.02661,null,0.047,null,0.99]
["     N",null,6,null,6,null,10]
["     Mean (SD)",null,-2.9,"(3.0)",-1.6,"(4.9)",-1.1,"(1.4)"]
["     Median",null,-1.5,null,-4,null,-0.8]
["     Minimum, Maximum",null,"-8.5,-1",null,"-5,8",null,"-3,2"]
["*Baseline p-value based on one-way analysis of variance; change from baseline p-value based on analysis of covariance"]
[" adjusting for baseline NIHSS."]
["Higher scores are worse."]

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["Swallowing  Recovery after Dysphagic Stroke, Sandeep Kumar, MD"]
["2019 Data and Safety Monitoring Board (DSMB) Meeting"]
[]
["Data as of: 01/31/2019"]
["Date of Report: 03/20/2019"]
[]
["Table 5.7: Functional Oral Intake Scale (NIHSS) Motor Scores - Intent-to-Treat Analysis Set"]
[]
["Characteristic",null,"Treatment 1 (N=15)",null,"Treatment 2 (N=13)",null,"Treatment 3 (N=14)",null,"P-Value T1 vs.T2*",null,"P-Value T1 vs. T3*",null,"P-Value T2 vs. T3*"]
["Baseline NIHSS MLA",{"$nulls":7},0.64,null,0.26,null,0.79]
["     N ",null,15,null,13,null,14]
["     Mean (SD)",null,1.8,"(2.0)",1.2,"(1.7)",0.8,"(1.6)"]
["     Median",null,0.5,null,0,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,4"]
["Day 2 NIHSS MLA"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,{"v":2,"d":"2.0"},"(2.1)",1.2,"(1.7)",0.7,"(1.4)"]
["     Median",null,0,null,0,null,4]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,4"]
["Change from Baseline to Day 2 NIHSS MLA",{"$nulls":7},0.88,null,0.41,null,0.69]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0,"(0.3)",0,"(0)","-0.1","(0.3)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-0.5,1",null,"0,0",null,"-1,0"]
["Day 3 NIHSS MLA"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,1.9,"(2.0)",0.8,"(1.5)",0.7,"(1.4)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,4"]
["Change from Baseline to Day 3 NIHSS MLA",{"$nulls":7},0.23,null,0.78,null,0.58]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0,"(0.4)",-0.4,"(1.1)",-0.1,"(0.3)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,1",null,"-4,0",null,"-1,0"]
["Day 4 NIHSS MLA"]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,1.9,"(2.0)",1.6,"(2)",0.9,"(1.6)"]
["     Median",null,1.5,null,0.5,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,4"]
["Change from Baseline to Day 4 NIHSS MLA",{"$nulls":7},0.72,null,0.73,null,0.99]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,0,"(0.4)",-0.1,"(0.4)",-0.1,"(0.3)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,1",null,"-1,0",null,"-1,0"]
["Day 5 NIHSS MLA"]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,1.6,"(2.0)",2,"(2.2)",1,"(1.6)"]
["     Median",null,0,null,2,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,4"]
["Change from Baseline to Day 5 NIHSS MLA",{"$nulls":7},0.99,null,0.83,null,0.85]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,0,"(0.6)",-0.2,"(0.4)",-0.1,"(0.3)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,1",null,"-1,0",null,"-1,0"]
["Baseline NIHSS MRA",{"$nulls":7},0.86,null,0.049,null,0.17]
["     N ",null,15,null,13,null,14]
["     Mean (SD)",null,0.7,"(1.3)",{"v":1,"d":"1.0"},"(1.5)",2.1,"(1.8)"]
["     Median",null,0,null,0,null,2]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,4"]
["Day 2 NIHSS MRA"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0.5,"(1.3)",1.1,"(1.6)",2.1,"(1.8)"]
["     Median",null,0,null,0,null,2]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,4"]
["Change from Baseline to Day 2 NIHSS MRA",{"$nulls":7},0.39,null,0.51,null,0.99]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,"-0.1","(0.4)",0,"(0.5)",0,"(0)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,0",null,"-1,1",null,"0,0"]
["Day 3 NIHSS MRA"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0.5,"(1.3)",1.2,"(1.6)",2,"(1.9)"]
["     Median",null,0,null,0,null,1.5]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,4"]
["Change from Baseline to Day 3 NIHSS MRA",{"$nulls":7},0.57,null,{"v":0.9,"d":"0.90"},null,0.86]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,"-0.1","(0.4)",0.1,"(1.2)",-0.1,"(0.4)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,0",null,"-1,4",null,"-1,0"]
["Day 4 NIHSS MRA"]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,0.7,"(1.4)",0.6,"(1.4)",2.1,"(2.0)"]
["     Median",null,0,null,0,null,3]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,4"]
["Change from Baseline to Day 4 NIHSS MRA",{"$nulls":7},0.76,null,0.99,null,0.81]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,-0.1,"(0.3)",-0.2,"(0.4)",-0.1,"(0.3)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,0",null,"-1,0",null,"-1,0"]
["Day 5 NIHSS MRA"]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,0.6,"(1.5)",0.5,"(1.2)",1.9,"(2.0)"]
["     Median",null,0,null,0,null,1.5]
["     Minimum, Maximum",null,"0,4",null,"0,3",null,"0,4"]
["Change from Baseline to Day 5 NIHSS MRA",{"$nulls":7},0.48,null,0.87,null,0.22]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,-0.1,"(0.4)",-0.5,"(0.8)","-0.1","(0.3)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,0",null,"-2,0",null,"-1,0"]
["Baseline NIHSS MLL",{"$nulls":7},0.93,null,0.35,null,0.22]
["     N ",null,15,null,13,null,14]
["     Mean (SD)",null,1.3,"(1.6)",1.5,"(1.7)",0.5,"(0.9)"]
["     Median",null,0,null,1,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,3"]
["Day 2 NIHSS MLL"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,1.2,"(1.5)",1,"(1.6)",0.6,"(1.1)"]
["     Median",null,0.5,null,0,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,3"]
["Change from Baseline to Day 2 NIHSS MLL",{"$nulls":7},0.32,null,0.81,null,0.12]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,-0.1,"(0.4)",-0.5,"(0.9)",0.1,"(0.3)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,0",null,"-3,0",null,"0,1"]
["Day 3 NIHSS MLL"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,1.4,"(1.6)",0.9,"(1.6)",0.4,"(0.9)"]
["     Median",null,1,null,0,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,3"]
["Change from Baseline to Day 3 NIHSS MLL",{"$nulls":7},0.07,null,{"v":0.5,"d":"0.50"},null,0.52]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0.1,"(0.5)",-0.5,"(1.1)",-0.1,"(0.3)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,1",null,"-4,0",null,"-1,0"]
["Day 4 NIHSS MLL"]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,1.3,"(1.5)",1.8,"(2.0)",0.6,"(1.0)"]
["     Median",null,0.5,null,1,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,3"]
["Change from Baseline to Day 4 NIHSS MLL",{"$nulls":7},{"v":0.1,"d":"0.10"},null,0.99,null,0.13]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,0,"(0)",-0.4,"(0.5)",0,"(0.4)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"0,0",null,"-1,0",null,"-1,1"]
["Day 5 NIHSS MLL"]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,1,"(1.5)",2.3,"(2.0)",0.7,"(1.1)"]
["     Median",null,0,null,3,null,0]
["     Minimum, Maximum",null,"0,4",null,"0,4",null,"0,3"]
["Change from Baseline to Day 5 NIHSS MLL",{"$nulls":7},{"v":0.1,"d":"0.10"},null,0.95,null,0.14]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,0,"(0)",-0.3,"(0.5)",-0.1,"(0.2)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"0,0",null,"-1,0",null,"-0.5,0"]
["Baseline NIHSS MRL",{"$nulls":7},0.95,null,0.038,null,0.09]
["     N ",null,15,null,13,null,14]
["     Mean (SD)",null,0.5,"(0.8)",0.6,"(1.1)",1.6,"(1.6)"]
["     Median",null,0,null,0,null,1]
["     Minimum, Maximum",null,"0,2",null,"0,3",null,"0,4"]
["Day 2 NIHSS MRL"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0.5,"(0.9)",0.6,"(1.1)",1.8,"(1.7)"]
["     Median",null,0,null,0,null,2]
["     Minimum, Maximum",null,"0,2",null,"0,3",null,"0,4"]
["Change from Baseline to Day 2 NIHSS MRL",{"$nulls":7},0.46,null,0.99,null,0.46]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0,"(0)",0,"(0.4)",0.1,"(0.4)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"0,0",null,"-1,1",null,"0,1"]
["Day 3 NIHSS MRL"]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0.5,"(0.9)",0.9,"(1.4)",1.6,"(1.8)"]
["     Median",null,0,null,0,null,1]
["     Minimum, Maximum",null,"0,3",null,"0,4",null,"0,4"]
["Change from Baseline to Day 3 NIHSS MRL",{"$nulls":7},0.55,null,0.58,null,0.99]
["     N",null,14,null,13,null,14]
["     Mean (SD)",null,0.3,"(1.2)",0.3,"(1.2)",-0.1,"(0.5)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,4",null,"-1,4",null,"-1,1"]
["Day 4 NIHSS MRL"]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,0.6,"(0.8)",0.5,"(1.1)",1.9,"(1.8)"]
["     Median",null,0,null,0,null,1]
["     Minimum, Maximum",null,"0,2",null,"0,3",null,"0,4"]
["Change from Baseline to Day 4 NIHSS MRL",{"$nulls":7},0.93,null,0.62,null,0.87]
["     N",null,12,null,8,null,11]
["     Mean (SD)",null,0,"(0.4)",0.1,"(0.4)",0.1,"(0.7)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,1",null,"0,1",null,"-1,1"]
["Day 5 NIHSS MRL"]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,0.5,"(0.8)",0.7,"(1.6)",1.8,"(2.0)"]
["     Median",null,0,null,0,null,0.8]
["     Minimum, Maximum",null,"0,2",null,"0,4",null,"0,4"]
["Change from Baseline to Day 5 NIHSS MRL",{"$nulls":7},0.43,null,0.44,null,0.99]
["     N",null,7,null,6,null,10]
["     Mean (SD)",null,"-0.2","(0.4)",0.2,"(0.4)",-0.2,"(0.7)"]
["     Median",null,0,null,0,null,0]
["     Minimum, Maximum",null,"-1,0",null,"0,1",null,"-2,1"]
["*Baseline p-value based on one-way analysis of variance; change from baseline p-value based on analysis of covariance"]
[" adjusting for baseline NIHSS."]
["0 is normal and 4 is worst."]