Trial Outcomes & Findings for Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects (NCT NCT01316770)

NCT ID: NCT01316770

Last Updated: 2018-11-02

Results Overview

Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and held in place by slight negative pressure. Collection time was 1 minute. The primary outcome measure is looking at change from baseline at Study Day 56 and not the flow at any particular time.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline (Study Day 0) to Study Day 56
• Results posted on: 2018-11-02

Participant Flow

14 participants were screened in the United States. Nine of the participants were then eligible and enrolled between October, 2011 and Sep, 2013 and administered treatment.

Screening occurred in two stages: Stage I (within 6 weeks before Stage II), and Stage II (within 6 weeks before randomization). Ten participants were eligible following the Stage I screening, but one subject loss their eligibility at Stage II screening because she refused the parotid biopsy.

Unit of analysis: parotid glands

Participant milestones

Measure	Dexamethasone Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Study STARTED	9 9	9 9
Overall Study COMPLETED	9 9	9 9
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

On January 9, 2013, the field for waist circumference was removed as a required field in the database collection forms. As of that date, only 2 participants had records for waist circumference entered into the database.

Baseline characteristics by cohort

Measure	Overall Study n=22 parotid glands Safety Population: all enrolled participants that received any parotid saline irrigation used to determine parotid filling volume during Stage I screening.
Age, Customized Age Category · 18-30 years	0 Participants n=11 Participants
Age, Customized Age Category · 31-40 years	2 Participants n=11 Participants
Age, Customized Age Category · 41-50 years	1 Participants n=11 Participants
Age, Customized Age Category · 51-60 years	6 Participants n=11 Participants
Age, Customized Age Category · 61-65 years	1 Participants n=11 Participants
Age, Customized Age Category · 66-70 years	0 Participants n=11 Participants
Age, Customized Age Category · Missing	1 Participants n=11 Participants
Sex: Female, Male Female	11 Participants n=11 Participants
Sex: Female, Male Male	0 Participants n=11 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants
Race (NIH/OMB) Asian	3 Participants n=11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants
Race (NIH/OMB) Black or African American	2 Participants n=11 Participants
Race (NIH/OMB) White	5 Participants n=11 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=11 Participants
Region of Enrollment United States	11 Participants n=11 Participants
Waist Circumference	98.0 cm n=2 Participants • On January 9, 2013, the field for waist circumference was removed as a required field in the database collection forms. As of that date, only 2 participants had records for waist circumference entered into the database.
Weight	68.95 kg n=6 Participants • On January 9, 2013, the field for weight was removed as a required field in the database collection forms. As of that date, only 6 participants had records for weight entered into the database.
Height	158.68 cm n=6 Participants • On January 9, 2013, the field for height was removed as a required field in the database collection forms. As of that date, only 6 participants had had records for height entered into the database.
Parotid Fill Volume Parotid randomized to dexamethasone irrigation	1.0 mL/min n=9 parotid glands • Two participants in the Safety population were never randomized. These two participants were thus entered in the table as "not randomized"
Parotid Fill Volume Parotid randomized to placebo irrigation	1.0 mL/min n=9 parotid glands • Two participants in the Safety population were never randomized. These two participants were thus entered in the table as "not randomized"
Parotid Fill Volume Not randomized, right-side parotid	0.875 mL/min n=2 parotid glands • Two participants in the Safety population were never randomized. These two participants were thus entered in the table as "not randomized"
Parotid Fill Volume Not randomized, left-side parotid	0.875 mL/min n=2 parotid glands • Two participants in the Safety population were never randomized. These two participants were thus entered in the table as "not randomized"
Saliva Flow Parotid randomized to dexamethasone irrigation	0.21250 mL/min STANDARD_DEVIATION 0.158850 • n=9 parotid glands • Two participants in the safety population were not randomized and thus their saliva flow was not recorded at their baseline randomization visit.
Saliva Flow Parotid randomized to placebo irrigation	0.19096 mL/min STANDARD_DEVIATION 0.136399 • n=9 parotid glands • Two participants in the safety population were not randomized and thus their saliva flow was not recorded at their baseline randomization visit.
Focus Score Parotid randomized to dexamethasone irrigation	2.5 score on a scale n=4 parotid glands • The biopsy to determine the Focus score was only performed on the right-side parotid, thus only half the parotids have focus scores at baseline (4 dexamethasone randomized parotids; 4 placebo randomized parotids). Three parotids (participants) did not have biopsies at baseline (Stage I Screening).
Focus Score Parotid randomized to placebo irrigation	1.5 score on a scale n=4 parotid glands • The biopsy to determine the Focus score was only performed on the right-side parotid, thus only half the parotids have focus scores at baseline (4 dexamethasone randomized parotids; 4 placebo randomized parotids). Three parotids (participants) did not have biopsies at baseline (Stage I Screening).
MRI Scan Evaluation Parotid randomized to dexamethasone irrigation · Normal	5 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Parotid randomized to dexamethasone irrigation · Abnormal ncs	4 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Parotid randomized to dexamethasone irrigation · Abnormal cs	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Parotid randomized to dexamethasone irrigation · Not done	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Parotid randomized to placebo irrigation · Normal	5 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Parotid randomized to placebo irrigation · Abnormal ncs	4 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Parotid randomized to placebo irrigation · Abnormal cs	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Parotid randomized to placebo irrigation · Not done	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Not randomized, right-side parotid · Normal	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Not randomized, right-side parotid · Abnormal ncs	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Not randomized, right-side parotid · Abnormal cs	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Not randomized, right-side parotid · Not done	2 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Not randomized, left-side parotid · Normal	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Not randomized, left-side parotid · Abnormal ncs	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Not randomized, left-side parotid · Abnormal cs	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
MRI Scan Evaluation Not randomized, left-side parotid · Not done	2 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Parotid randomized to dexamethasone irrigation · Normal	4 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Parotid randomized to dexamethasone irrigation · Abnormal	5 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Parotid randomized to dexamethasone irrigation · Not done	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Placebo randomized parotid: Normal · Normal	4 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Placebo randomized parotid: Normal · Abnormal	5 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Placebo randomized parotid: Normal · Not done	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Not randomized, right-side parotid · Normal	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Not randomized, right-side parotid · Abnormal	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Not randomized, right-side parotid · Not done	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Not randomized, left-side parotid · Normal	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Not randomized, left-side parotid · Abnormal	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation Not randomized, left-side parotid · Not done	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Parotid randomized to dexamethasone irrigation · Yes	9 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Parotid randomized to dexamethasone irrigation · No	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Parotid randomized to dexamethasone irrigation · Not done	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Parotid randomized to placebo irrigation · Yes	9 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Parotid randomized to placebo irrigation · No	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Parotid randomized to placebo irrigation · Not done	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Not randomized, right-side parotid · Yes	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Not randomized, right-side parotid · No	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Not randomized, right-side parotid · Not done	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Not randomized, left-side parotid · Yes	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Not randomized, left-side parotid · No	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake Not randomized, left-side parotid · Not done	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Parotid randomized to dexamethasone irrigation · Yes	8 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Parotid randomized to dexamethasone irrigation · No	1 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Parotid randomized to dexamethasone irrigation · Not done	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Parotid randomized to placebo irrigation · Yes	7 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Parotid randomized to placebo irrigation · No	2 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Parotid randomized to placebo irrigation · Not done	0 parotid glands n=9 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Not randomized, right-side parotid · Yes	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Not randomized, right-side parotid · No	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Not randomized, right-side parotid · Not done	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Not randomized, left-side parotid · Yes	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Not randomized, left-side parotid · No	0 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation Not randomized, left-side parotid · Not done	1 parotid glands n=2 parotid glands • Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"

PRIMARY outcome

Timeframe: Baseline (Study Day 0) to Study Day 56

Population: Primary Efficacy Population (PEP): all enrolled participants who receive all parotid irrigations on study Days 0 and 28, have the same treatment applied to the same parotid (regardless of random assignment) at both visits, and have values for the primary endpoint (i.e., change in salivary flow from Day 0 to Day 56).

Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and held in place by slight negative pressure. Collection time was 1 minute. The primary outcome measure is looking at change from baseline at Study Day 56 and not the flow at any particular time.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.	-0.01120 g/min Standard Error 0.049063	-0.05204 g/min Standard Error 0.032029

SECONDARY outcome

Timeframe: Baseline to 14 days post-baseline

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 14 and not the flow at any particular time.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Parotid gland from one side of the mouth Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=9 Parotid gland from one side of the mouth Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14.	-0.01106 g/min Standard Error 0.075004	0.01875 g/min Standard Error 0.047825

SECONDARY outcome

Timeframe: Baseline to 28 days post-baseline

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 28 and not the flow at any particular time.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Parotid gland on one side of the mouth Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=9 Parotid gland on one side of the mouth Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28.	-0.09808 g/min Standard Error 0.058960	-0.06678 g/min Standard Error 0.071649

SECONDARY outcome

Timeframe: Baseline to 42 days post-baseline

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 42 and not the flow at any particular time.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Parotid galnd on one side of the mouth Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=9 Parotid galnd on one side of the mouth Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42.	0.00224 g/min Standard Deviation 0.055472	0.01192 g/min Standard Deviation 0.031049

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Study Day 42 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Stage II Screening · Yes	3 Participants	—
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Stage II Screening · No	6 Participants	—
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Study Day 14 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Study Day 14 · No	8 Participants	—
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Study Day 28 · Yes	2 Participants	—
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Study Day 28 · No	7 Participants	—
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Study Day 42 · No	8 Participants	—
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Study Day 56 · Yes	2 Participants	—
Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? Study Day 56 · No	7 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 28 · Weakness	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 28 · Too few Teeth	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 28 · Other	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 42 · Pain	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 42 · Dryness	1 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 42 · Weakness	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 42 · Too few Teeth	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 42 · Other	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 56 · Pain	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 56 · Dryness	2 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 56 · Weakness	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 56 · Too few Teeth	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 56 · Other	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Stage II Screening · Pain	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Stage II Screening · Dryness	3 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Stage II Screening · Weakness	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Stage II Screening · Too few Teeth	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Stage II Screening · Other	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 14 · Pain	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 14 · Dryness	1 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 14 · Weakness	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 14 · Too few Teeth	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 14 · Other	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 28 · Pain	0 Participants	—
Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? Study Day 28 · Dryness	2 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Stage II Screening · Yes	0 Participants	—
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Stage II Screening · No	9 Participants	—
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Study Day 14 · Yes	0 Participants	—
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Study Day 14 · No	9 Participants	—
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Study Day 28 · Yes	0 Participants	—
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Study Day 28 · No	9 Participants	—
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Study Day 42 · Yes	0 Participants	—
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Study Day 42 · No	9 Participants	—
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Study Day 56 · Yes	0 Participants	—
Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? Study Day 56 · No	9 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Stage II Screening · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Stage II Screening · No	8 Participants	—
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Study Day 14 · Yes	2 Participants	—
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Study Day 14 · No	7 Participants	—
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Study Day 28 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Study Day 28 · No	8 Participants	—
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Study Day 42 · Yes	0 Participants	—
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Study Day 42 · No	9 Participants	—
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Study Day 56 · Yes	0 Participants	—
Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? Study Day 56 · No	9 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Stage II Screening · Foods taste different than they used to	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Stage II Screening · Foods taste less intense (for example, less sweet)	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Stage II Screening · Foods taste more intense (for example, more sweet)	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Stage II Screening · I have persistent bad taste in my mouth	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 14 · Foods taste different than they used to	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 14 · Foods taste less intense (for example, less sweet)	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 14 · Foods taste more intense (for example, more sweet)	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 14 · I have persistent bad taste in my mouth	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 28 · Foods taste different than they used to	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 28 · Foods taste less intense (for example, less sweet)	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 28 · Foods taste more intense (for example, more sweet)	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 28 · I have persistent bad taste in my mouth	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 42 · Foods taste different than they used to	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 42 · Foods taste less intense (for example, less sweet)	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 42 · Foods taste more intense (for example, more sweet)	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 42 · I have persistent bad taste in my mouth	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 56 · Foods taste different than they used to	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 56 · Foods taste less intense (for example, less sweet)	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 56 · Foods taste more intense (for example, more sweet)	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: Study Day 56 · I have persistent bad taste in my mouth	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Study Day 28 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Stage II Screening · Yes	2 Participants	—
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Stage II Screening · No	7 Participants	—
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Study Day 14 · Yes	2 Participants	—
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Study Day 14 · No	7 Participants	—
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Study Day 28 · No	8 Participants	—
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Study Day 42 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Study Day 42 · No	8 Participants	—
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Study Day 56 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? Study Day 56 · No	8 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 28 · Mouth or tongue burns	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 28 · I have tooth pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Stage II Screening · Mouth or tongue burns	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Stage II Screening · I have tooth pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Stage II Screening · I have gum pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Stage II Screening · I have pain in my jaws or TMJ	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 14 · Mouth or tongue burns	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 14 · I have tooth pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 14 · I have gum pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 14 · I have pain in my jaws or TMJ	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 28 · I have gum pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 28 · I have pain in my jaws or TMJ	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 42 · Mouth or tongue burns	1 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 42 · I have tooth pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 42 · I have gum pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 42 · I have pain in my jaws or TMJ	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 56 · Mouth or tongue burns	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 56 · I have tooth pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 56 · I have gum pain	0 Participants	—
Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify: Study Day 56 · I have pain in my jaws or TMJ	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Stage II Screening · Yes	8 Participants	—
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Stage II Screening · No	1 Participants	—
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Study Day 14 · Yes	9 Participants	—
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Study Day 14 · No	0 Participants	—
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Study Day 28 · Yes	9 Participants	—
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Study Day 28 · No	0 Participants	—
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Study Day 42 · Yes	9 Participants	—
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Study Day 42 · No	0 Participants	—
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Study Day 56 · Yes	8 Participants	—
Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? Study Day 56 · No	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Baseline: Sip water	8 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Baseline: Sip liquids other than water	6 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Baseline: use commercial products	4 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Baseline: Chew sugared gum or mints	1 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Baseline: Chew sugarless gum or mints	2 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 14: Sip water	8 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 14: Sip liquids other than water	6 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 14: use commercial products	3 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 14: Chew sugared gum or mints	1 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 14: Chew sugarless gum or mints	4 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 28: Sip water	8 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 28: Sip liquids other than water	7 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 28: use commercial products	4 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 28: Chew sugared gum or mints	2 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 28: Chew sugarless gum or mints	3 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 42: Sip water	7 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 42: Sip liquids other than water	5 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 42: use commercial products	3 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 42: Chew sugared gum or mints	2 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 42: Chew sugarless gum or mints	3 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 56: Sip water	8 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 56: Sip liquids other than water	3 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 56: use commercial products	3 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 56: Chew sugared gum or mints	1 Participants	—
Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: Study Day 56: Chew sugarless gum or mints	2 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Stage II Screening · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Stage II Screening · No	6 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Stage II Screening · Not Sure	2 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 14 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 14 · No	7 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 14 · Not Sure	1 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 28 · Yes	2 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 28 · No	7 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 28 · Not Sure	0 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 42 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 42 · No	8 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 42 · Not Sure	0 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 56 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 56 · No	7 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? Study Day 56 · Not Sure	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Stage II Screening · Yes	3 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Stage II Screening · No	6 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Stage II Screening · Not Sure	0 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 14 · Yes	5 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 14 · No	3 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 14 · Not Sure	1 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 28 · Yes	3 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 28 · No	5 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 28 · Not Sure	1 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 42 · Yes	2 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 42 · No	5 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 42 · Not Sure	2 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 56 · Yes	2 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 56 · No	6 Participants	—
Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? Study Day 56 · Not Sure	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: To little; to much; Do not notice it.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 56 · Too little	4 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 56 · Too much	0 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 56 · Do not notice it	5 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Stage II Screening · Too little	4 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Stage II Screening · Too much	0 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Stage II Screening · Do not notice it	5 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 14 · Too little	6 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 14 · Too much	0 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 14 · Do not notice it	3 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 28 · Too little	5 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 28 · Too much	0 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 28 · Do not notice it	4 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 42 · Too little	5 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 42 · Too much	0 Participants	—
Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: Study Day 42 · Do not notice it	4 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Stage II Screening · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Stage II Screening · No	8 Participants	—
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Study Day 14 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Study Day 14 · No	8 Participants	—
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Study Day 28 · Yes	3 Participants	—
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Study Day 28 · No	6 Participants	—
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Study Day 42 · Yes	3 Participants	—
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Study Day 42 · No	6 Participants	—
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Study Day 56 · Yes	1 Participants	—
Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? Study Day 56 · No	8 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 14 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 14 · Screening II: Yes; Study Day: No	2 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 14 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 14 · Screening II: No; Study Day: No	6 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 28 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 28 · Screening II: Yes; Study Day: No	2 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 28 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 28 · Screening II: No; Study Day: No	5 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 42 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 42 · Screening II: Yes; Study Day: No	2 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 42 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 42 · Screening II: No; Study Day: No	6 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 56 · Screening II: Yes; Study Day: Yes	2 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 56 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 56 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? Study Day 56 · Screening II: No; Study Day: No	6 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 14 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 14 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 14 · Screening II: No; Study Day: No	9 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 28 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 28 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 28 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 28 · Screening II: No; Study Day: No	9 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 42 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 42 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 42 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 42 · Screening II: No; Study Day: No	9 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 56 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 56 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 56 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 56 · Screening II: No; Study Day: No	9 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? Study Day 14 · Screening II: Yes; Study Day: No	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on Study Days 42 and 56.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 14 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 14 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 14 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 14 · Screening II: No; Study Day: No	7 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 28 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 28 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 28 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 28 · Screening II: No; Study Day: No	7 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 42 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 42 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 42 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 42 · Screening II: No; Study Day: No	8 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 56 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 56 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 56 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? Study Day 56 · Screening II: No; Study Day: No	8 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 14 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 14 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 14 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 14 · Screening II: No; Study Day: No	6 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 28 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 28 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 28 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 28 · Screening II: No; Study Day: No	7 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 42 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 42 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 42 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 42 · Screening II: No; Study Day: No	7 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 56 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 56 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 56 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? Study Day 56 · Screening II: No; Study Day: No	7 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 14 · Screening II: Yes; Study Day: Yes	8 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 14 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 14 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 14 · Screening II: No; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 28 · Screening II: Yes; Study Day: Yes	8 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 28 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 28 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 28 · Screening II: No; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 42 · Screening II: Yes; Study Day: Yes	8 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 42 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 42 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 42 · Screening II: No; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 56 · Screening II: Yes; Study Day: Yes	8 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 56 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 56 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? Study Day 56 · Screening II: No; Study Day: No	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.

Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 14 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 14 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 14 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 14 · Screening II: No; Study Day: No	5 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 28 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 28 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 28 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 28 · Screening II: No; Study Day: No	6 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 42 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 42 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 42 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 42 · Screening II: No; Study Day: No	6 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 56 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 56 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 56 · Screening II: No; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? Study Day 56 · Screening II: No; Study Day: No	5 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.

Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 14 · Screening II: Yes; Study Day: Yes	2 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 14 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 14 · Screening II: No; Study Day: Yes	3 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 14 · Screening II: No; Study Day: No	3 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 28 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 28 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 28 · Screening II: No; Study Day: Yes	2 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 28 · Screening II: No; Study Day: No	4 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 42 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 42 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 42 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 42 · Screening II: No; Study Day: No	5 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 56 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 56 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 56 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? Study Day 56 · Screening II: No; Study Day: No	5 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.

Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 14 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 14 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 14 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 14 · Screening II: No; Study Day: No	7 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 28 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 28 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 28 · Screening II: No; Study Day: Yes	3 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 28 · Screening II: No; Study Day: No	5 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 42 · Screening II: Yes; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 42 · Screening II: Yes; Study Day: No	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 42 · Screening II: No; Study Day: Yes	2 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 42 · Screening II: No; Study Day: No	6 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 56 · Screening II: Yes; Study Day: Yes	0 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 56 · Screening II: Yes; Study Day: No	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 56 · Screening II: No; Study Day: Yes	1 Participants	—
Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? Study Day 56 · Screening II: No; Study Day: No	7 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.

Ordinal Scale 0:least to 10:greatest level of disease activity

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) Baseline	5 units on a scale Interval 4.0 to 7.0	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) Study Day 14	5 units on a scale Interval 4.0 to 7.0	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) Study Day 28	5 units on a scale Interval 4.0 to 7.0	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) Study Day 42	5 units on a scale Interval 5.0 to 7.0	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) Study Day 56	5 units on a scale Interval 5.0 to 7.0	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.

Nominal scale values: Inactive; Low; Moderate; High

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Baseline · Inactive	0 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Baseline · Low	2 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Baseline · Moderate	7 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Baseline · High	0 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 14 · Inactive	0 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 14 · Low	2 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 14 · Moderate	7 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 14 · High	0 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 28 · Inactive	0 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 28 · Low	2 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 28 · Moderate	7 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 28 · High	0 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 42 · Inactive	0 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 42 · Low	3 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 42 · Moderate	6 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 42 · High	0 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 56 · Inactive	0 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 56 · Low	4 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 56 · Moderate	5 Participants	—
Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) Study Day 56 · High	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.

Response: Yes or No

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Study Day 14 · No	9 Participants	—
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Baseline · Yes	0 Participants	—
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Baseline · No	9 Participants	—
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Study Day 14 · Yes	0 Participants	—
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Study Day 28 · Yes	0 Participants	—
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Study Day 28 · No	9 Participants	—
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Study Day 42 · Yes	0 Participants	—
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Study Day 42 · No	9 Participants	—
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Study Day 56 · Yes	0 Participants	—
Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? Study Day 56 · No	9 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.

Ordinal Scale 0: least to 10: greatest level of disease activity.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores Baseline	5 score on a scale Interval 5.0 to 7.0	—
Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores Study Day 14	5 score on a scale Interval 5.0 to 7.0	—
Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores Study Day 28	5 score on a scale Interval 5.0 to 7.0	—
Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores Study Day 42	5 score on a scale Interval 5.0 to 7.0	—
Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores Study Day 56	5 score on a scale Interval 4.0 to 7.0	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.

Nominal Scale: Much better; Better; The same; Worse; Much worse

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Baseline · Much better	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Baseline · Better	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Baseline · The same	7 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Baseline · Worse	2 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Baseline · Much worse	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 14 · Much better	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 14 · Better	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 14 · The same	7 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 14 · Worse	2 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 14 · Much worse	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 28 · Much better	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 28 · Better	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 28 · The same	7 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 28 · Worse	2 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 28 · Much worse	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 42 · Much better	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 42 · Better	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 42 · The same	9 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 42 · Worse	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 42 · Much worse	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 56 · Much better	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 56 · Better	1 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 56 · The same	8 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 56 · Worse	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: Study Day 56 · Much worse	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Response: Yes; No

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Baseline · Yes	1 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Baseline · No	8 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Study 14 · Yes	2 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Study 14 · No	7 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Study Day 28 · Yes	2 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Study Day 28 · No	7 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Study Day 42 · Yes	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Study Day 42 · No	9 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Study Day 56 · Yes	0 Participants	—
Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome): Study Day 56 · No	9 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Possible Response: Yes or No

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. Study Day 14 · Yes	0 Participants	—
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. Study Day 14 · No	9 Participants	—
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. Study Day 28 · Yes	0 Participants	—
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. Study Day 28 · No	9 Participants	—
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. Study Day 42 · Yes	0 Participants	—
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. Study Day 42 · No	9 Participants	—
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. Study Day 56 · Yes	0 Participants	—
Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days. Study Day 56 · No	9 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 14

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores Baseline SDAI=5; Study Day 14 SDAI=5	4 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores Baseline SDAI=5; Study Day 14 SDAI=6	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores Baseline SDAI=6; Study Day 14 SDAI=5	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores Baseline SDAI=6; Study Day 14 SDAI=6	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores Baseline SDAI=6; Study Day 14 SDAI=7	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores Baseline SDAI=7; Study Day 14 SDAI=7	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 28

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores Baseline SDAI=5; Study Day 28 SDAI=5	4 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores Baseline SDAI=5; Study Day 28 SDAI=6	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores Baseline SDAI=6; Study Day 28 SDAI=5	2 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores Baseline SDAI=6; Study Day 28 SDAI=7	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores Baseline SDAI=7; Study Day 28 SDAI=7	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 42

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores Baseline SDAI=5; Study Day 42 SDAI=5	4 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores Baseline SDAI=5; Study Day 42 SDAI=6	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores Baseline SDAI=6; Study Day 42 SDAI=5	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores Baseline SDAI=6; Study Day 42 SDAI=6	2 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores Baseline SDAI=7; Study Day 42 SDAI=7	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores Baseline SDAI=5; Study Day 56 SDAI=4	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores Baseline SDAI=5; Study Day 56 SDAI=5	3 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores Baseline SDAI=5; Study Day 56 SDAI=6	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores Baseline SDAI=6; Study Day 56 SDAI=5	2 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores Baseline SDAI=6; Study Day 56 SDAI=6	1 Participants	—
Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores Baseline SDAI=7; Study Day 56 SDAI=7	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) to Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Possible response on nominal scale: Inactive; Low; Moderate; High SDAI.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Inactive to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Inactive to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Inactive to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Inactive to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Low to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Low to Study Day Low	2 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Low to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Low to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Moderate to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Moderate to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Moderate to Study Day Moderate	7 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline Moderate to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline High to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline High to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline High to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 14 · Baseline High to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Inactive to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Inactive to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Inactive to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Inactive to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Low to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Low to Study Day Low	2 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Low to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Low to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Moderate to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Moderate to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Moderate to Study Day Moderate	7 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline Moderate to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline High to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline High to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline High to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 28 · Baseline High to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Inactive to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Inactive to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Inactive to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Inactive to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Low to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Low to Study Day Low	2 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Low to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Low to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Moderate to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Moderate to Study Day Low	1 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Moderate to Study Day Moderate	6 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline Moderate to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline High to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline High to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline High to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 42 · Baseline High to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Inactive to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Inactive to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Inactive to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Inactive to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Low to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Low to Study Day Low	2 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Low to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Low to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Moderate to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Moderate to Study Day Low	2 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Moderate to Study Day Moderate	5 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline Moderate to Study Day High	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline High to Study Day Inactive	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline High to Study Day Low	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline High to Study Day Moderate	0 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale Study Day 56 · Baseline High to Study Day High	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) to Study Day 14

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale Baseline SDAI=4; Study Day 14 SDAI=4	1 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale Baseline SDAI=5; Study Day 14 SDAI=5	4 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale Baseline SDAI=6; Study Day 14 SDAI=5	2 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale Baseline SDAI=6; Study Day 14 SDAI=7	1 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale Baseline SDAI=7; Study Day 14 SDAI=7	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) to Study Day 28

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale Baseline SDAI=6; Study Day 28 SDAI=5	2 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale Baseline SDAI=4; Study Day 28 SDAI=4	1 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale Baseline SDAI=5; Study Day 28 SDAI=5	4 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale Baseline SDAI=6; Study Day 28 SDAI=7	1 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale Baseline SDAI=7; Study Day 28 SDAI=7	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) to Study Day 42

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale Baseline SDAI=4; Study Day 42 SDAI=5	1 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale Baseline SDAI=5; Study Day 42 SDAI=5	4 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale Baseline SDAI=6; Study Day 42 SDAI=5	3 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale Baseline SDAI=7; Study Day 42 SDAI=7	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Study Day 0) to Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale Baseline SDAI=4; Study Day 56 SDAI=5	1 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale Baseline SDAI=5; Study Day 56 SDAI=5	4 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale Baseline SDAI=6; Study Day 56 SDAI=5	3 Participants	—
Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale Baseline SDAI=7; Study Day 56 SDAI=7	1 Participants	—

SECONDARY outcome

Timeframe: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Medical evaluations of MRI Scans. Possible evaluations include: i) Normal; ii) Abnormal, not clinically significant; iii) Abnormal, clinically significant.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Summary Statistics of MRI Scans Stage II Screening Visit · MRI Abnormal, clinically signficant	0 Participants	0 Participants
Summary Statistics of MRI Scans Stage II Screening Visit · MRI Normal	5 Participants	5 Participants
Summary Statistics of MRI Scans Stage II Screening Visit · MRI Abnormal, not clinically signficant	4 Participants	4 Participants
Summary Statistics of MRI Scans Study Day 56 · MRI Normal	5 Participants	6 Participants
Summary Statistics of MRI Scans Study Day 56 · MRI Abnormal, not clinically signficant	3 Participants	3 Participants
Summary Statistics of MRI Scans Study Day 56 · MRI Abnormal, clinically signficant	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Change in the evaluations of the parotid MRI scans at Study Day 56 from Stage II Screening Visit. Possible MRI evaluations at both Baseline and Study Day 56 include: i)Normal; ii) Abnormal, not clinically significant (Abnormal ncs); and iii) Abnormal, clinically significant (Abnormal cs).

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit Screening Normal; Study Day 56 Normal	4 Participants	5 Participants
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit Screening Normal; Study Day 56 Abnormal ncs	0 Participants	0 Participants
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit Screening Normal; Study Day 56 Abnormal cs	1 Participants	0 Participants
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit Screening Abnormal ncs; Study Day 56 Normal	1 Participants	1 Participants
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit Screening Abnormal ncs; Study Day 56 Abnormal ncs	3 Participants	3 Participants
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit Screening Abnormal ncs; Study Day 56 Abnormal cs	0 Participants	0 Participants
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit Screening Abnormal cs; Study Day 56 Normal	0 Participants	0 Participants
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit Screening Abnormal cs; Study Day 56 Abnormal ncs	0 Participants	0 Participants
Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit Screening Abnormal cs; Study Day 56 Abnormal cs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Medical evaluations of Technetium Scans. Possible evaluations include: i) Normal; and ii) Abnormal.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Summary Statistics of Technetium Scans Stage II Screening Visit · Normal	4 Participants	4 Participants
Summary Statistics of Technetium Scans Stage II Screening Visit · Abnormal	5 Participants	5 Participants
Summary Statistics of Technetium Scans Study Day 56 · Normal	4 Participants	5 Participants
Summary Statistics of Technetium Scans Study Day 56 · Abnormal	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56

Population: Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.

Change in the evaluations of the parotid technetium scans at Study Day 56 from Stage II Screening Visit. Possible technetium scan evaluations at both Baseline and Study Day 56 include: Normal; Abnormal.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=9 Participants Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit Screening Normal; Study Day 56 Normal	4 Participants	4 Participants
Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit Baseline Normal; Study Day 56 Abnormal	0 Participants	0 Participants
Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit Baseline Abnormal; Study Day 56 Normal	0 Participants	1 Participants
Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit Baseline Abnormal; Study Day 56 Abnormal	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Stage II screening (within 6 wks before baseline) through 56 days post-baseline

Population: Secondary Efficacy Population (SEP). Since only the right parotid was biopsied, 9 parotids were biopsied (5 dexamethasone and 4 placebo randomized parotids). At Screening only 4/5 dexamethasone and 4/4 placebo randomized parotids were biopsied. At Study Day 56 only 3/5 dexamethasone and 4/4 placebo randomized parotids were biopsied.

Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Focus scores ≥1 are key criteria used in the diagnosis of inflammation in the oral component of Sjögren's Syndrome. Higher numbers are associated with more inflammation. (Range 0-12).

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=4 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=4 Participants Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Summary Statistics of Focus Score Stage II Screening	2.5 score on a scale Interval 1.0 to 12.0	1.5 score on a scale Interval 0.0 to 2.0
Summary Statistics of Focus Score Study Day 56	1 score on a scale Interval 0.0 to 3.0	0.5 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Stage II Screening (within 6 wks before baseline) through 56 days post-baseline

Population: Secondary Efficacy Population (SEP). Since only the right parotid was biopsied, 9 parotids were biopsied (5 dexamethasone and 4 placebo randomized parotids). At Screening only 4/5 dexamethasone and 4/4 placebo randomized parotids were biopsied. At Study Day 56 only 3/5 dexamethasone and 4/4 placebo randomized parotids were biopsied.

Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Table data are the shift in focus score from Stage II Screening to Study Day 56. Only shift table cells with more than 0 participants were included in the Outcome Measure Data Table below.

Outcome measures

Measure	Dexamethasone Irrigation of Parotid Gland n=5 Participants Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.	Placebo Irrigation of Parotid Gland n=4 Participants Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Shift Table of Focus Scores From Stage II Screening to Study Day 56 Screening Focus=0; Day 56 Focus=0	0 Participants	1 Participants
Shift Table of Focus Scores From Stage II Screening to Study Day 56 Screening Focus=1; Day 56 Focus=1	1 Participants	1 Participants
Shift Table of Focus Scores From Stage II Screening to Study Day 56 Screening Focus=2; Day 56 Focus=0	1 Participants	1 Participants
Shift Table of Focus Scores From Stage II Screening to Study Day 56 Screening Focus=2; Day 56 Focus=5	0 Participants	1 Participants
Shift Table of Focus Scores From Stage II Screening to Study Day 56 Screening Focus=3; Day 56 Focus=not done	1 Participants	0 Participants
Shift Table of Focus Scores From Stage II Screening to Study Day 56 Screening Focus=12; Day 56 Focus=3	1 Participants	0 Participants
Shift Table of Focus Scores From Stage II Screening to Study Day 56 Screening Focus=not done; Day 56 Focus=not done	1 Participants	0 Participants

Adverse Events

Dexamethasone Irrigation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Irrigation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Side of Mouth Not Applicable

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dexamethasone Irrigation n=9 participants at risk Adverse event from the side of the mouth that received the parotid dexamethasone irrigation	Placebo Irrigation n=9 participants at risk Adverse event from the side of the mouth that received the parotid placebo irrigation	Side of Mouth Not Applicable n=9 participants at risk Side of mouth is not applicable to the adverse event
Gastrointestinal disorders Constipation	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	11.1% 1/9 • Number of events 1 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
Gastrointestinal disorders Parotid gland enlargement	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	22.2% 2/9 • Number of events 2 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
Investigations Hepatic enzyme increased	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	11.1% 1/9 • Number of events 1 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
Nervous system disorders Aphonia	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	11.1% 1/9 • Number of events 1 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
Nervous system disorders Dysgeusia	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	11.1% 1/9 • Number of events 1 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
Nervous system disorders Migraine	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	11.1% 1/9 • Number of events 1 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
Ear and labyrinth disorders Vertigo	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	11.1% 1/9 • Number of events 1 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
Skin and subcutaneous tissue disorders Ecchymosis	11.1% 1/9 • Number of events 1 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.	0.00% 0/9 • Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days). Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.

Additional Information

Ilias Alevizos

NIDCR/NIH

Phone: 3014966207

Email: alevizosi@mail.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place