Trial Outcomes & Findings for Intranasal Vasopressin Treatment in Children With Autism (NCT NCT03204786)

NCT ID: NCT03204786

Last Updated: 2025-09-19

Results Overview

Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. The SRS-2 is reported as a total score (T-Score Range: 37 to above 90), and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-compatible Social Communication and Interaction (SCI) score (T-Score Range: 36 to above 90) and Restricted Interests and Repetitive Behavior (RRB) score (T-Score range: 41 to above 90). A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores correspond to greater symptom levels (≤ 59: within normal limits; 60-65: mild range; 66-75: moderate range; ≥ 76: severe range). Change is reported as 4-week minus the baseline score, and 8-week minus the 4-week score. For this outcome, the baseline score is the average of the screening visit and baseline visit (average approximately 2 to 3 weeks after the screening visit).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

157 participants

Primary outcome timeframe

baseline, 4-week, 8-week

Results posted on

2025-09-19

Participant Flow

Participants were randomized to one of three groups for two 4-week treatment periods. Participants in the Placebo-Placebo group were given the opportunity to enroll in a 4-week open-label extension period.

323 participants were screened. 157 participants signed informed consent, and 108 were randomized.

Participant milestones

Participant milestones
Measure	Vasopressin-Vasopressin 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Placebo 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)
Treatment Period 1 (4 Weeks) STARTED	23	46	39
Treatment Period 1 (4 Weeks) Received Intervention	23	44	39
Treatment Period 1 (4 Weeks) COMPLETED	22	41	39
Treatment Period 1 (4 Weeks) NOT COMPLETED	1	5	0
Treatment Period 2 (4 Weeks) STARTED	21	38	39
Treatment Period 2 (4 Weeks) COMPLETED	19	38	36
Treatment Period 2 (4 Weeks) NOT COMPLETED	2	0	3
Open-label Extension (4 Weeks) STARTED	0	0	32
Open-label Extension (4 Weeks) COMPLETED	0	0	29
Open-label Extension (4 Weeks) NOT COMPLETED	0	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intranasal Vasopressin Treatment in Children With Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=44 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Total n=106 Participants Total of all reporting groups
Age, Continuous	10.35 years STANDARD_DEVIATION 3.24 • n=5 Participants	10.41 years STANDARD_DEVIATION 3.23 • n=7 Participants	10.72 years STANDARD_DEVIATION 3.5 • n=5 Participants	10.51 years STANDARD_DEVIATION 3.31 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	38 Participants n=7 Participants	34 Participants n=5 Participants	92 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	31 Participants n=7 Participants	27 Participants n=5 Participants	75 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants	30 Participants n=4 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Multiracial	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	47 Participants n=4 Participants
Region of Enrollment United States	23 Participants n=5 Participants	44 Participants n=7 Participants	39 Participants n=5 Participants	106 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline, 4-week, 8-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=22 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=41 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. Total score - baseline	82.2281 T-score Standard Error 1.5650	81.3690 T-score Standard Error 2.1052	79.6795 T-score Standard Error 1.5448	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. Total score - change from baseline at 4-week	-6.4832 T-score Standard Error 1.2695	-5.6779 T-score Standard Error 1.6830	-4.5448 T-score Standard Error 1.2298	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. Total score - 4-week	74.8816 T-score Standard Error 1.5650	75.0000 T-score Standard Error 2.1052	74.7821 T-score Standard Error 1.5448	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. Total score - change from week 4 at week 8	-1.0443 T-score Standard Error 1.3267	-3.4420 T-score Standard Error 1.7758	-5.3854 T-score Standard Error 1.2964	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. SCI score - baseline	81.5987 T-score Standard Error 1.5531	81.2500 T-score Standard Error 2.0892	79.3333 T-score Standard Error 1.5330	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. SCI score - change from baseline at 4-week	-6.3462 T-score Standard Error 1.2385	-5.6451 T-score Standard Error 1.6475	-4.6366 T-score Standard Error 1.2024	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. SCI score - 4-week	74.5263 T-score Standard Error 1.5531	74.9405 T-score Standard Error 2.0892	74.3718 T-score Standard Error 1.5330	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. SCI score - change from week 4 at week 8	-0.9782 T-score Standard Error 1.2962	-2.8205 T-score Standard Error 1.7326	-5.1550 T-score Standard Error 1.2689	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. RRB score - baseline	80.4408 T-score Standard Error 1.7155	78.0000 T-score Standard Error 2.3077	77.0128 T-score Standard Error 1.6934	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. RRB score - change from baseline at 4-week	-6.2517 T-score Standard Error 1.4083	-5.4830 T-score Standard Error 1.8580	-3.5584 T-score Standard Error 1.3617	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. RRB score - 4-week	72.6974 T-score Standard Error 1.7155	71.8095 T-score Standard Error 2.3077	73.0641 T-score Standard Error 1.6934	—	—	—	—
Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. RRB score - change from week 4 at week 8	-0.9253 T-score Standard Error 1.4705	-5.4995 T-score Standard Error 1.9770	-5.4625 T-score Standard Error 1.4287	—	—	—	—

SECONDARY outcome

Timeframe: baseline; 4-week; 8-week

Population: Participants with data at the respective time point

Clinician assessment of CGI severity (CGI-S) and CGI improvement (CGI-I) scores. * Higher scores on the CGI-S mean greater social and communication deficits (range: 1 to 7). * Lower scores on the CGI-I correspond to greater improvement in the areas assessed in the CGI-S, and higher scores correspond to worsening (range: 1 to 7). There is no baseline score for the CGI-I, it represents the clinician's subjective assessment of change.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=22 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=41 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. CGI-S score - baseline	4.7692 score on a scale Standard Error 0.09058	4.8182 score on a scale Standard Error 0.1206	4.6585 score on a scale Standard Error 0.08834	—	—	—	—
Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. CGI-S score - change from baseline at 4-week	-0.02467 score on a scale Standard Error 0.02562	0.001903 score on a scale Standard Error 0.03413	-0.00113 score on a scale Standard Error 0.02499	—	—	—	—
Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. CGI-S score - 4-week	4.7416 score on a scale Standard Error 0.09070	4.8177 score on a scale Standard Error 0.1209	4.6576 score on a scale Standard Error 0.08846	—	—	—	—
Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. CGI-S score - change from 4-week at 8-week	-0.02795 score on a scale Standard Error 0.02651	-0.05149 score on a scale Standard Error 0.03633	-0.00254 score on a scale Standard Error 0.02589	—	—	—	—
Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. CGI-I: 4-week (end of treatment period 1)	3.8205 score on a scale Standard Error 0.08503	3.8636 score on a scale Standard Error 0.1132	3.7073 score on a scale Standard Error 0.08293	—	—	—	—
Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. CGI-I: 8-week (end of treatment period 2)	3.7307 score on a scale Standard Error 0.08777	3.5892 score on a scale Standard Error 0.1200	3.5899 score on a scale Standard Error 0.08547	—	—	—	—

SECONDARY outcome

Timeframe: baseline; 4-week; 8-week

Population: Participants with data at the respective time point

Score range: 0 to 28; higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. Baseline	15.5789 score on a scale Standard Error 1.2648	16.5556 score on a scale Standard Error 1.8377	14.7222 score on a scale Standard Error 1.2995	—	—	—	—
Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. Change from baseline at 4-week	-0.4319 score on a scale Standard Error 0.8267	1.6440 score on a scale Standard Error 1.2030	-0.02870 score on a scale Standard Error 0.8518	—	—	—	—
Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. 4-week	15.2876 score on a scale Standard Error 1.3064	18.3273 score on a scale Standard Error 1.9019	14.8889 score on a scale Standard Error 1.2995	—	—	—	—
Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. Change from 4-week at 8-week	-0.2156 score on a scale Standard Error 0.8771	-0.2844 score on a scale Standard Error 1.3008	0.5628 score on a scale Standard Error 0.8510	—	—	—	—

SECONDARY outcome

Timeframe: baseline; 4-week; 8-week

Population: Participants with data at the respective time point

Score range: 0 to 42; higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on the Facial Emotion Recognition Test During Treatment. Baseline	31.3333 score on a scale Standard Error 1.6336	25.2667 score on a scale Standard Error 1.9330	30.3913 score on a scale Standard Error 1.5610	—	—	—	—
Change From Baseline on the Facial Emotion Recognition Test During Treatment. Change from baseline at 4-week	-0.1705 score on a scale Standard Error 0.8543	0.05134 score on a scale Standard Error 1.0362	0.2458 score on a scale Standard Error 0.8136	—	—	—	—
Change From Baseline on the Facial Emotion Recognition Test During Treatment. 4-week	30.7990 score on a scale Standard Error 1.6449	26.3341 score on a scale Standard Error 1.9736	30.3846 score on a scale Standard Error 1.5814	—	—	—	—
Change From Baseline on the Facial Emotion Recognition Test During Treatment. Change from 4-week at 8-week	1.7945 score on a scale Standard Error 0.8736	2.3733 score on a scale Standard Error 1.0904	-0.5105 score on a scale Standard Error 0.8605	—	—	—	—

SECONDARY outcome

Timeframe: baseline; 4-week; 8-week

Population: Participants with data at the respective time point

Score range: 0 to 129; higher scores on the RBS-R mean higher levels of repetitive and restricted behaviors.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. Baseline	32.6154 score on a scale Standard Error 2.8720	24.9872 score on a scale Standard Error 3.8628	26.4763 score on a scale Standard Error 2.9263	—	—	—	—
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. Change from baseline at 4-week	-5.4530 score on a scale Standard Error 1.8509	-1.4292 score on a scale Standard Error 2.4939	-4.6282 score on a scale Standard Error 1.8785	—	—	—	—
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. 4-week	27.9896 score on a scale Standard Error 2.9411	22.7130 score on a scale Standard Error 4.0020	21.4958 score on a scale Standard Error 2.9623	—	—	—	—
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. Change from 4-week at 8-week	-0.08268 score on a scale Standard Error 1.9332	-4.5054 score on a scale Standard Error 2.6993	-2.1610 score on a scale Standard Error 1.9440	—	—	—	—

SECONDARY outcome

Timeframe: baseline; 4-week; 8-week

Population: Participants with data at the respective time point

Scale measuring severity of anxiety symptoms. Score range: 0 to 114; higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. Baseline	17.4681 score on a scale Standard Error 1.6970	18.9944 score on a scale Standard Error 2.3258	16.0513 score on a scale Standard Error 1.6862	—	—	—	—
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. Change from baseline at 4-week	-2.5485 score on a scale Standard Error 1.0439	-2.1798 score on a scale Standard Error 1.4413	-2.5005 score on a scale Standard Error 1.0257	—	—	—	—
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. 4-week	13.8016 score on a scale Standard Error 1.7202	14.7648 score on a scale Standard Error 2.3563	14.0044 score on a scale Standard Error 1.7201	—	—	—	—
Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. Change from 4-week at 8-week	-1.1805 score on a scale Standard Error 1.0743	-3.1160 score on a scale Standard Error 1.4720	-3.9195 score on a scale Standard Error 1.0731	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. Baseline	86.7 milliseconds Standard Deviation 1.18	87.9 milliseconds Standard Deviation 1.88	86.5 milliseconds Standard Deviation 1.53	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. 4-weeks (end of treatment period 1)	87.0 milliseconds Standard Deviation 1.44	83.7 milliseconds Standard Deviation 2.11	87.1 milliseconds Standard Deviation 1.88	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. 8-weeks (end of treatment period 2)	84.4 milliseconds Standard Deviation 1.36	88.2 milliseconds Standard Deviation 2.03	85.6 milliseconds Standard Deviation 1.5	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. 12-weeks (end of open-label extension)	89.6 milliseconds Standard Deviation 1.33	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. Baseline	137 milliseconds Standard Deviation 2.34	136 milliseconds Standard Deviation 3.48	138 milliseconds Standard Deviation 2.38	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. 4-weeks (end of treatment period 1)	140 milliseconds Standard Deviation 2.6	136 milliseconds Standard Deviation 3.48	139 milliseconds Standard Deviation 3.02	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. 8-weeks (end of treatment period 2)	139 milliseconds Standard Deviation 2.95	135 milliseconds Standard Deviation 2.96	141 milliseconds Standard Deviation .345	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. 12-weeks (end of open-label extension)	142 milliseconds Standard Deviation 2.73	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. 8-weeks (end of treatment period 2)	86.2 milliseconds Standard Deviation 1.7	29.3 milliseconds Standard Deviation 0.87	89.2 milliseconds Standard Deviation 1.52	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. Baseline	86.7 milliseconds Standard Deviation 1.44	87.3 milliseconds Standard Deviation 1.76	89.5 milliseconds Standard Deviation 1.27	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. 4-weeks (end of treatment period 1)	86.5 milliseconds Standard Deviation 1.24	89.5 milliseconds Standard Deviation 2.45	88.6 milliseconds Standard Deviation 41.5	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. 12-weeks (end of open-label extension)	84.6 milliseconds Standard Deviation 1.52	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. Baseline	348 milliseconds Standard Deviation 4.05	399 milliseconds Standard Deviation 6.03	355 milliseconds Standard Deviation 3.61	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. 4-weeks (end of treatment period 1)	350 milliseconds Standard Deviation 4.27	352 milliseconds Standard Deviation 6.94	365 milliseconds Standard Deviation 4.24	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. 8-weeks (end of treatment period 2)	354 milliseconds Standard Deviation 5.23	355 milliseconds Standard Deviation 5.37	359 milliseconds Standard Deviation 4.79	—	—	—	—
Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. 12-weeks (end of open-label extension)	344 milliseconds Standard Deviation 4.00	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. Baseline	139 mmol/L Standard Deviation 0.434	139 mmol/L Standard Deviation 0.457	139 mmol/L Standard Deviation 0.252	—	—	—	—
Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. 4-weeks (end of treatment period 1)	139 mmol/L Standard Deviation 0.232	139 mmol/L Standard Deviation 0.434	139 mmol/L Standard Deviation 0.293	—	—	—	—
Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. 8-weeks (end of treatment period 2)	139 mmol/L Standard Deviation 0.34	140 mmol/L Standard Deviation 0.402	139 mmol/L Standard Deviation 0.426	—	—	—	—
Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. 12-weeks (end of open-label extension)	139 mmol/L Standard Deviation 0.291	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. Baseline	4.21 mmol/L Standard Deviation 0.0564	4.07 mmol/L Standard Deviation 0.0661	4.14 mmol/L Standard Deviation 0.0497	—	—	—	—
Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. 4-weeks (end of treatment period 1)	4.3 mmol/L Standard Deviation 0.0751	4.07 mmol/L Standard Deviation 0.0374	4.13 mmol/L Standard Deviation 0.049	—	—	—	—
Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. 8-weeks (end of treatment period 2)	4.24 mmol/L Standard Deviation 0.0859	4.16 mmol/L Standard Deviation 0.0922	4.17 mmol/L Standard Deviation 0.0714	—	—	—	—
Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. 12-weeks (end of open-label extension)	4.12 mmol/L Standard Deviation 0.0742	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Change from baseline on blood clinical labs (Chloride) during treatment.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. Baseline	102 mmol/L Standard Error 0.291	103 mmol/L Standard Error 0.375	103 mmol/L Standard Error 0.298	—	—	—	—
Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. 4-weeks (end of treatment period 1)	103 mmol/L Standard Error 0.296	103 mmol/L Standard Error 0.502	103 mmol/L Standard Error 0.305	—	—	—	—
Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. 8-weeks (end of treatment period 2)	102 mmol/L Standard Error 0.313	103 mmol/L Standard Error 0.501	102 mmol/L Standard Error 0.362	—	—	—	—
Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. 12-weeks (end of open-label extension)	102 mmol/L Standard Error 0.308	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (CO2) During Treatment. Baseline	25.2 mmol/L Standard Error 0.279	25 mmol/L Standard Error 0.574	25.1 mmol/L Standard Error 0.273	—	—	—	—
Change From Baseline on Blood Clinical Labs (CO2) During Treatment. 4-weeks (end of treatment period 1)	25.7 mmol/L Standard Error 0.452	25.5 mmol/L Standard Error 0.515	25.3 mmol/L Standard Error 0.291	—	—	—	—
Change From Baseline on Blood Clinical Labs (CO2) During Treatment. 8-weeks (end of treatment period 2)	25.3 mmol/L Standard Error 0.374	25.8 mmol/L Standard Error 0.505	24.8 mmol/L Standard Error 0.321	—	—	—	—
Change From Baseline on Blood Clinical Labs (CO2) During Treatment. 12-weeks (end of open-label extension)	25 mmol/L Standard Error 0.362	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. Baseline	11 mmol/L Standard Error 0.34	11.3 mmol/L Standard Error 0.524	11.6 mmol/L Standard Error 0.291	—	—	—	—
Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. 4-weeks (end of treatment period 1)	10.8 mmol/L Standard Error 0.482	11 mmol/L Standard Error 0.439	11.1 mmol/L Standard Error 0.384	—	—	—	—
Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. 8-weeks (end of treatment period 2)	11.5 mmol/L Standard Error 0.479	10.8 mmol/L Standard Error 0.763	11.6 mmol/L Standard Error 0.34	—	—	—	—
Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. 12-weeks (end of open-label extension)	10.9 mmol/L Standard Error 0.446	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. Baseline	94.9 mg/dL Standard Error 2.21	95.7 mg/dL Standard Error 2.75	94.4 mg/dL Standard Error 1.85	—	—	—	—
Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. 4-weeks (end of treatment period 1)	94.8 mg/dL Standard Error 2.29	99 mg/dL Standard Error 2.8	93.7 mg/dL Standard Error 2.33	—	—	—	—
Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. 8-weeks (end of treatment period 2)	94.5 mg/dL Standard Error 2.27	93.5 mg/dL Standard Error 1.31	94.2 mg/dL Standard Error 2.25	—	—	—	—
Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. 12-weeks (end of open-label extension)	97 mg/dL Standard Error 2.84	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. Baseline	0.515 mg/dL Standard Error 0.0257	0.473 mg/dL Standard Error 0.0297	0.502 mg/dL Standard Error 0.0243	—	—	—	—
Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. 4-weeks (end of treatment period 1)	0.523 mg/dL Standard Error 0.0294	0.505 mg/dL Standard Error 0.037	0.503 mg/dL Standard Error 0.0256	—	—	—	—
Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. 8-weeks (end of treatment period 2)	0.517 mg/dL Standard Error 0.0258	0.531 mg/dL Standard Error 0.048	0.508 mg/dL Standard Error 0.0273	—	—	—	—
Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. 12-weeks (end of open-label extension)	0.5 mg/dL Standard Error 0.0257	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. Baseline	13.7 mg/dL Standard Error 0.465	12.8 mg/dL Standard Error 0.691	13.7 mg/dL Standard Error 0.462	—	—	—	—
Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. 4-weeks (end of treatment period 1)	13.4 mg/dL Standard Error 0.587	12.6 mg/dL Standard Error 0.827	13.4 mg/dL Standard Error 0.588	—	—	—	—
Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. 8-weeks (end of treatment period 2)	14 mg/dL Standard Error 0.683	14.2 mg/dL Standard Error 0.957	12.2 mg/dL Standard Error 0.618	—	—	—	—
Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. 12-weeks (end of open-label extension)	13.8 mg/dL Standard Error 0.638	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. Baseline	9.55 mg/dL Standard Error 0.0673	9.45 mg/dL Standard Error 0.0797	9.54 mg/dL Standard Error 0.0443	—	—	—	—
Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. 4-weeks (end of treatment period 1)	9.62 mg/dL Standard Error 0.0492	9.5 mg/dL Standard Error 0.0809	9.57 mg/dL Standard Error 0.0564	—	—	—	—
Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. 8-weeks (end of treatment period 2)	9.67 mg/dL Standard Error 0.0568	9.67 mg/dL Standard Error 0.0642	9.6 mg/dL Standard Error 0.0671	—	—	—	—
Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. 12-weeks (end of open-label extension)	9.85 mg/dL Standard Error 0.058	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. Baseline	290 mOsm/kg Standard Error 1.03	289 mOsm/kg Standard Error 1.03	289 mOsm/kg Standard Error 0.735	—	—	—	—
Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. 4-weeks (end of treatment period 1)	291 mOsm/kg Standard Error 1.13	289 mOsm/kg Standard Error 1.19	289 mOsm/kg Standard Error 0.839	—	—	—	—
Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. 8-weeks (end of treatment period 2)	290 mOsm/kg Standard Error 0.935	291 mOsm/kg Standard Error 1.28	288 mOsm/kg Standard Error 0.937	—	—	—	—
Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. 12-weeks (end of open-label extension)	290 mOsm/kg Standard Error 1.29	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. Baseline	827 mOsm/kg Standard Error 47.3	757 mOsm/kg Standard Error 72.6	843 mOsm/kg Standard Error 38.2	—	—	—	—
Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. 4-weeks (end of treatment period 1)	815 mOsm/kg Standard Error 45.5	758 mOsm/kg Standard Error 70.3	810 mOsm/kg Standard Error 44.8	—	—	—	—
Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. 8-weeks (end of treatment period 2)	838 mOsm/kg Standard Error 47.9	834 mOsm/kg Standard Error 68.3	732 mOsm/kg Standard Error 48.1	—	—	—	—
Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. 12-weeks (end of open-label extension)	875 mOsm/kg Standard Error 60.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=22 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=41 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 n=19 Participants Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 n=38 Participants Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 n=36 Participants Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin n=29 Participants Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. Sitting	112 mmHg Standard Error 1.58	114 mmHg Standard Error 2.78	107 mmHg Standard Error 2.38	111 mmHg Standard Error 3.32	109 mmHg Standard Error 2.22	110 mmHg Standard Error 1.96	111 mmHg Standard Error 2.03
Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. Standing	111 mmHg Standard Error 1.71	110 mmHg Standard Error 2.13	109 mmHg Standard Error 1.99	108 mmHg Standard Error 2.44	107 mmHg Standard Error 1.79	112 mmHg Standard Error 2.47	113 mmHg Standard Error 2.13
Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. Change from standing to sitting	-1.00 mmHg Standard Error 1.44	-3.25 mmHg Standard Error 2.16	1.47 mmHg Standard Error 1.67	-4.06 mmHg Standard Error 3.86	-2.53 mmHg Standard Error 1.34	1.47 mmHg Standard Error 1.69	2.04 mmHg Standard Error 1.71

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=22 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=41 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 n=19 Participants Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 n=38 Participants Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 n=36 Participants Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin n=29 Participants Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. Sitting	67.2 mmHg Standard Error 1.79	65.8 mmHg Standard Error 3.47	63.4 mmHg Standard Error 1.34	69.3 mmHg Standard Error 3.75	63.6 mmHg Standard Error 1.42	66.9 mmHg Standard Error 1.75	65.1 mmHg Standard Error 2.11
Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. Standing	67.0 mmHg Standard Error 1.57	70.7 mmHg Standard Error 3.08	62.3 mmHg Standard Error 1.72	68.8 mmHg Standard Error 1.41	65.5 mmHg Standard Error 1.58	66.6 mmHg Standard Error 1.96	67.8 mmHg Standard Error 1.80
Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. Change from standing to sitting	0.167 mmHg Standard Error 1.60	4.90 mmHg Standard Error 3.02	-1.11 mmHg Standard Error 1.84	-1.00 mmHg Standard Error 3.96	1.72 mmHg Standard Error 1.59	-0.118 mmHg Standard Error 2.11	2.65 mmHg Standard Error 2.49

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=22 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=41 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 n=19 Participants Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 n=38 Participants Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 n=36 Participants Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin n=29 Participants Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Vital Signs (Pulse) During Treatment. Sitting	94.3 beats per minute (BPM) Standard Error 2.45	88.4 beats per minute (BPM) Standard Error 3.40	84.2 beats per minute (BPM) Standard Error 2.11	89.2 beats per minute (BPM) Standard Error 4.06	90.0 beats per minute (BPM) Standard Error 2.95	90.7 beats per minute (BPM) Standard Error 2.40	94.9 beats per minute (BPM) Standard Error 3.95
Change From Baseline on Vital Signs (Pulse) During Treatment. Standing	103 beats per minute (BPM) Standard Error 2.43	99.6 beats per minute (BPM) Standard Error 3.02	94.8 beats per minute (BPM) Standard Error 2.39	100 beats per minute (BPM) Standard Error 4.01	102 beats per minute (BPM) Standard Error 2.91	105 beats per minute (BPM) Standard Error 3.44	107 beats per minute (BPM) Standard Error 3.98
Change From Baseline on Vital Signs (Pulse) During Treatment. Change from standing to sitting	10.1 beats per minute (BPM) Standard Error 1.65	11.2 beats per minute (BPM) Standard Error 2.25	10.6 beats per minute (BPM) Standard Error 1.37	10.9 beats per minute (BPM) Standard Error 2.29	11.9 beats per minute (BPM) Standard Error 1.77	14.2 beats per minute (BPM) Standard Error 2.41	11.2 beats per minute (BPM) Standard Error 2.84

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Height During Treatment. Baseline	145 cm Standard Error 2.78	145 cm Standard Error 3.91	146 cm Standard Error 2.98	—	—	—	—
Change From Baseline on Height During Treatment. 4-weeks (end of treatment period 1)	146 cm Standard Error 2.76	142 cm Standard Error 5.96	148 cm Standard Error 3.21	—	—	—	—
Change From Baseline on Height During Treatment. 8-weeks (end of treatment period 2)	146 cm Standard Error 2.68	145 cm Standard Error 4.43	148 cm Standard Error 3.22	—	—	—	—
Change From Baseline on Height During Treatment. 12-weeks (end of open-label extension)	145 cm Standard Error 3.26	—	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline to 4-week, 8-week, and 12-week

Population: Participants with available data at the respective time point

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=23 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=46 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on Weight During Treatment. Baseline	45.7 kg Standard Error 3.15	43.2 kg Standard Error 3.92	45.2 kg Standard Error 4.24	—	—	—	—
Change From Baseline on Weight During Treatment. 4-weeks (end of treatment period 1)	46.6 kg Standard Error 3.17	43.9 kg Standard Error 4.47	46.6 kg Standard Error 4.92	—	—	—	—
Change From Baseline on Weight During Treatment. 8-weeks (end of treatment period 2)	46.8 kg Standard Error 3.22	43.0 kg Standard Error 4.83	44.0 kg Standard Error 3.38	—	—	—	—
Change From Baseline on Weight During Treatment. 12-weeks (end of open-label extension)	47.6 kg Standard Error 4.34	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants with available data at the respective time point

The DOTES evaluates a subset of symptoms related to various medical conditions. The clinician assesses intensity (0=Not assessed, 1=Not present, 2=Mild, 3=Moderate, 4=Severe), relatedness (0=None, 1=Remote, 2=Possible, 3=Probable, 4=Defined), and action taken (0=None, 1=Increased , 2=Contractive Rx, 3=Change Dose, 4=Change Dose Plus Contractive Rx, 5=Suspend Rx, 6=Discontinue Rx). Side effects are included that have increased in severity, become more likely to be related, or require action. Change from baseline is reported as the number of participants with change in these side effects during treatment.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=22 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=42 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 n=21 Participants Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 n=38 Participants Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 n=39 Participants Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin n=32 Participants Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Dizziness	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Constipation	4 Participants	2 Participants	0 Participants	2 Participants	4 Participants	1 Participants	0 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Diarrhea	3 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Dry Mouth	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Saliva Hypersecretion	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Vomiting or Nausea	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	3 Participants	1 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Decreased Appetite	1 Participants	0 Participants	3 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Increased Appetite	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Agitation	3 Participants	2 Participants	3 Participants	2 Participants	2 Participants	3 Participants	1 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Headache	3 Participants	2 Participants	4 Participants	0 Participants	5 Participants	4 Participants	4 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Initial Insomnia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Middle Insomnia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Unspecified Insomnia	0 Participants	0 Participants	3 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Aggression	10 Participants	1 Participants	8 Participants	5 Participants	8 Participants	7 Participants	8 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Depressed Mood	2 Participants	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Hyperactivity	1 Participants	0 Participants	4 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Nasal Congestion	13 Participants	2 Participants	6 Participants	5 Participants	6 Participants	10 Participants	7 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Pruritus	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. Rash	2 Participants	0 Participants	3 Participants	1 Participants	3 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 2-week, 4-week; 6-week, 8-week

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4-week; 8-week

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Adverse events collated according to intensity for each pre-allocated treatment group.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=39 Participants 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin n=22 Participants 8 weeks of vasopressin nasal spray (16 international units twice daily)	Placebo-Vasopressin n=42 Participants 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily)	Vasopressin-Vasopressin Group - Treatment Period 2 n=21 Participants Parameter assessed in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 n=38 Participants Parameter assessed in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 n=39 Participants Parameter assessed in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin n=32 Participants Parameter assessed in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Adverse Event Severity Mild	23 Participants	12 Participants	28 Participants	13 Participants	20 Participants	23 Participants	16 Participants
Adverse Event Severity Moderate	18 Participants	3 Participants	15 Participants	5 Participants	13 Participants	13 Participants	9 Participants
Adverse Event Severity Severe	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Adverse Event Severity Life-threatening	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Adverse Event Severity Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Deaths: 0 deaths

Open-label Vasopressin

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vasopressin-Vasopressin Group - Treatment Period 1 n=22 participants at risk Adverse events occurring in the Vasopressin-Vasopressin group during the first 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 1 n=42 participants at risk Adverse events occurring in the Placebo-Vasopressin group during the first 4-week treatment period (while receiving placebo).	Placebo-Placebo Group - Treatment Period 1 n=39 participants at risk Adverse events occurring in the Placebo-Placebo group during the first 4-week treatment period (while receiving placebo).	Vasopressin-Vasopressin Group - Treatment Period 2 n=21 participants at risk Adverse events occurring in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Vasopressin Group - Treatment Period 2 n=38 participants at risk Adverse events occurring in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug).	Placebo-Placebo Group - Treatment Period 2 n=39 participants at risk Adverse events occurring in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo).	Open-label Vasopressin n=32 participants at risk Adverse events occurring in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug).
Cardiac disorders Dizziness	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Ear and labyrinth disorders Earache	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Eye disorders Dilated Pupils	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Eye disorders Eye Redness	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Eye disorders Eyelid Edema	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	5.1% 2/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Eye disorders Hordeolum	0.00% 0/22 • UP to 12 week	4.8% 2/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Eye disorders Lacrimation Increased	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Abdominal Pain	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Constipation	9.1% 2/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	10.3% 4/39 • UP to 12 week	9.5% 2/21 • UP to 12 week	10.5% 4/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Diarrhea	0.00% 0/22 • UP to 12 week	4.8% 2/42 • UP to 12 week	7.7% 3/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	5.3% 2/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Dry Mouth	0.00% 0/22 • UP to 12 week	4.8% 2/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Fecal Incontinence	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Flatuence	4.5% 1/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Pharyngeal Pain	4.5% 1/22 • UP to 12 week	4.8% 2/42 • UP to 12 week	12.8% 5/39 • UP to 12 week	9.5% 2/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	6.2% 2/32 • UP to 12 week
Gastrointestinal disorders Saliva Hypersecretion	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Throat Burning Sensation	0.00% 0/22 • UP to 12 week	7.1% 3/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Tooth Pain	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Gastrointestinal disorders Vomiting or Nausea	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	5.3% 2/38 • UP to 12 week	7.7% 3/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
General disorders Pyrexia	4.5% 1/22 • UP to 12 week	4.8% 2/42 • UP to 12 week	10.3% 4/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	5.3% 2/38 • UP to 12 week	5.1% 2/39 • UP to 12 week	6.2% 2/32 • UP to 12 week
Immune system disorders Seasonal Allergy	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Infections and infestations Bronchitis	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Infections and infestations Ear Infection	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Infections and infestations Sinusitis	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/22 • UP to 12 week	7.1% 3/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	5.3% 2/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Metabolism and nutrition disorders Increased Appetite	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Musculoskeletal and connective tissue disorders Muscle Pain	4.5% 1/22 • UP to 12 week	7.1% 3/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Nervous system disorders Agitation	9.1% 2/22 • UP to 12 week	7.1% 3/42 • UP to 12 week	7.7% 3/39 • UP to 12 week	9.5% 2/21 • UP to 12 week	5.3% 2/38 • UP to 12 week	7.7% 3/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Nervous system disorders Headache	9.1% 2/22 • UP to 12 week	9.5% 4/42 • UP to 12 week	7.7% 3/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	13.2% 5/38 • UP to 12 week	10.3% 4/39 • UP to 12 week	12.5% 4/32 • UP to 12 week
Nervous system disorders Initial Insomnia	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Nervous system disorders Middle Insomnia	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Nervous system disorders Sedation	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Nervous system disorders Somnolence	0.00% 0/22 • UP to 12 week	7.1% 3/42 • UP to 12 week	5.1% 2/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	5.3% 2/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Nervous system disorders Unspecified Insomnia	0.00% 0/22 • UP to 12 week	7.1% 3/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	5.3% 2/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Aggression	4.5% 1/22 • UP to 12 week	19.0% 8/42 • UP to 12 week	25.6% 10/39 • UP to 12 week	23.8% 5/21 • UP to 12 week	21.1% 8/38 • UP to 12 week	17.9% 7/39 • UP to 12 week	25.0% 8/32 • UP to 12 week
Psychiatric disorders Anal Picking	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Anxiety	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Depressed Mood	4.5% 1/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	5.1% 2/39 • UP to 12 week	9.5% 2/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Psychiatric disorders Echopraxia	4.5% 1/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Finger Sucking	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Hyperactivity	0.00% 0/22 • UP to 12 week	9.5% 4/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Psychiatric disorders Impulsive Behavior	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Inappropriate Sexual Behavior	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Inattention	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Irritability or Anger	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Nail Biting	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	5.1% 2/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Nightmares	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Psychomotor Retardation	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Psychiatric disorders Screaming	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	5.1% 2/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Psychiatric disorders Wandering Behavior	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Renal and urinary disorders Dysuria	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Renal and urinary disorders Enuresis	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Respiratory, thoracic and mediastinal disorders Cough	4.5% 1/22 • UP to 12 week	7.1% 3/42 • UP to 12 week	12.8% 5/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	5.3% 2/38 • UP to 12 week	15.4% 6/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Respiratory, thoracic and mediastinal disorders Gag Reflex Abnormal	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Respiratory, thoracic and mediastinal disorders Nasal Congestion	9.1% 2/22 • UP to 12 week	14.3% 6/42 • UP to 12 week	33.3% 13/39 • UP to 12 week	23.8% 5/21 • UP to 12 week	15.8% 6/38 • UP to 12 week	25.6% 10/39 • UP to 12 week	21.9% 7/32 • UP to 12 week
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	9.1% 2/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Respiratory, thoracic and mediastinal disorders Nasal Pain	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Respiratory, thoracic and mediastinal disorders Nose Bleed	0.00% 0/22 • UP to 12 week	7.1% 3/42 • UP to 12 week	7.7% 3/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	5.1% 2/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Respiratory, thoracic and mediastinal disorders Runny Nose	0.00% 0/22 • UP to 12 week	4.8% 2/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Respiratory, thoracic and mediastinal disorders Sneezing	4.5% 1/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	10.3% 4/39 • UP to 12 week	9.5% 2/21 • UP to 12 week	5.3% 2/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/32 • UP to 12 week
Respiratory, thoracic and mediastinal disorders Snoring	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Skin and subcutaneous tissue disorders Bug Bite	4.5% 1/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	2.6% 1/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/22 • UP to 12 week	2.4% 1/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	0.00% 0/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Skin and subcutaneous tissue disorders Rash	0.00% 0/22 • UP to 12 week	7.1% 3/42 • UP to 12 week	5.1% 2/39 • UP to 12 week	4.8% 1/21 • UP to 12 week	7.9% 3/38 • UP to 12 week	5.1% 2/39 • UP to 12 week	3.1% 1/32 • UP to 12 week
Skin and subcutaneous tissue disorders Scratch	0.00% 0/22 • UP to 12 week	0.00% 0/42 • UP to 12 week	0.00% 0/39 • UP to 12 week	0.00% 0/21 • UP to 12 week	0.00% 0/38 • UP to 12 week	2.6% 1/39 • UP to 12 week	0.00% 0/32 • UP to 12 week

Additional Information

Antonio Hardan, MD

Stanford University

Phone: (650)736-1235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place