Trial Outcomes & Findings for Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users (NCT NCT06247488)

NCT ID: NCT06247488

Last Updated: 2024-08-12

Results Overview

Mean difference in Drug Liking Emax over 24 hours for Drug Liking ("At this moment, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 110 participants
• Primary outcome timeframe: approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase
• Results posted on: 2024-08-12

Participant Flow

110 volunteers consented for the study and entered into a qualification phase.

In the qualification phase subjects were given a naloxone challenge to rule out drug dependent participants. Those that passed the challenge were randomized to get crossover doses of placebo and Oxycodone in random order to ensure they could tolerate and detect the effects of Oxy. 72 subjects completed qualification and 9 of those did not proceed to the treatment phase. 63 started the treatment phase and got at least one dose of study drug. 54 completed and were analyzed.

Participant milestones

Measure	ABFCED Period 1 Placebo, Period 2 Oxycodone (Oxy) 20mg, Period 3 Gabapentin Enacarbil Immediate Release (GE-IR) 450mg, Period 4 GE-IR 200mg + Oxy 20mg, Period 5 GE-IR 200mg, Period 6 GE-IR 450 + Oxy 20mg	BCADFE Period 1 Oxy 20 mg, Period 2 GE-IR 200mg + Oxy 20mg, Period 3 Placebo, Period 4 GE-IR 450 + Oxy 20mg, Period 5 GE-IR 450 mg, Period 6 GE-IR 200	CBDEAF Period 1 GE-IR 200mg + Oxy 20mg, Period 2 GE-IR 450 + Oxy 20mg, Period 3 Oxy 20 mg, Period 4 GE-IR 200mg. Period 5 Placebo, Period 6 GE-IR 450	DECFBA Period 1 GE-IR 450 + Oxy 20mg, Period 2 GE-IR 200 mg, Period 3 GE-IR 200 mg + Oxy 20mg, Period 4 GE-IR 450 mg, Period 5 Oxy 20 mg, Period 6 Placebo	EFDACB Period 1 GE-IR 200 mg, Period 2 GE-IR 450 mg, Period 3 GE-IR 450 mg + 20 mg Oxy, Period 4 Placebo, Period 5 GE-IR 200 mg + Oxy 20 mg, Period 6 Oxy 20 mg	FAEBDC Period 1 GE-IR 450 mg, Period 2 Placebo, Period 3 GE-IR 200 mg, Period 4 Oxy 20 mg, Period 5 GE-IR 450 mg + 20 mg Oxy, Period 6 GE-IR 200 mg + Oxy 20 mg
First Intervention (1 Day) STARTED	10	10	11	12	10	10
First Intervention (1 Day) COMPLETED	10	10	11	12	10	10
First Intervention (1 Day) NOT COMPLETED	0	0	0	0	0	0
First Washout (3 Days) STARTED	10	10	11	12	10	10
First Washout (3 Days) COMPLETED	10	10	11	12	10	10
First Washout (3 Days) NOT COMPLETED	0	0	0	0	0	0
Second Intervention (1 Day) STARTED	10	10	11	12	10	10
Second Intervention (1 Day) COMPLETED	10	10	11	12	10	10
Second Intervention (1 Day) NOT COMPLETED	0	0	0	0	0	0
Washout From 2nd Dose (3 Days) STARTED	10	10	11	12	10	10
Washout From 2nd Dose (3 Days) COMPLETED	9	10	11	11	10	10
Washout From 2nd Dose (3 Days) NOT COMPLETED	1	0	0	1	0	0
Third Intervention (1 Day) STARTED	9	10	11	11	10	10
Third Intervention (1 Day) COMPLETED	9	10	11	11	10	10
Third Intervention (1 Day) NOT COMPLETED	0	0	0	0	0	0
Washout of Third Dose (3 Days) STARTED	9	10	11	11	10	10
Washout of Third Dose (3 Days) COMPLETED	8	10	11	11	10	10
Washout of Third Dose (3 Days) NOT COMPLETED	1	0	0	0	0	0
Fourth Intervention (One Day) STARTED	8	10	11	11	10	10
Fourth Intervention (One Day) COMPLETED	8	10	11	11	10	10
Fourth Intervention (One Day) NOT COMPLETED	0	0	0	0	0	0
Washout of Fourth Dose (3 Days) STARTED	8	10	11	11	10	10
Washout of Fourth Dose (3 Days) COMPLETED	8	10	11	10	10	10
Washout of Fourth Dose (3 Days) NOT COMPLETED	0	0	0	1	0	0
Fifth Intervention (1 Day) STARTED	8	10	11	10	10	10
Fifth Intervention (1 Day) COMPLETED	8	10	11	10	10	10
Fifth Intervention (1 Day) NOT COMPLETED	0	0	0	0	0	0
Washout of 5th Dose (3 Days) STARTED	8	10	11	10	10	10
Washout of 5th Dose (3 Days) COMPLETED	8	9	10	10	10	7
Washout of 5th Dose (3 Days) NOT COMPLETED	0	1	1	0	0	3
Sixth Intervention (1 Day) STARTED	8	9	10	10	10	7
Sixth Intervention (1 Day) COMPLETED	8	9	10	10	10	7
Sixth Intervention (1 Day) NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Measure	ABFCED Period 1 Placebo, Period 2 Oxycodone (Oxy) 20mg, Period 3 Gabapentin Enacarbil Immediate Release (GE-IR) 450mg, Period 4 GE-IR 200mg + Oxy 20mg, Period 5 GE-IR 200mg, Period 6 GE-IR 450 + Oxy 20mg	BCADFE Period 1 Oxy 20 mg, Period 2 GE-IR 200mg + Oxy 20mg, Period 3 Placebo, Period 4 GE-IR 450 + Oxy 20mg, Period 5 GE-IR 450 mg, Period 6 GE-IR 200	CBDEAF Period 1 GE-IR 200mg + Oxy 20mg, Period 2 GE-IR 450 + Oxy 20mg, Period 3 Oxy 20 mg, Period 4 GE-IR 200mg. Period 5 Placebo, Period 6 GE-IR 450	DECFBA Period 1 GE-IR 450 + Oxy 20mg, Period 2 GE-IR 200 mg, Period 3 GE-IR 200 mg + Oxy 20mg, Period 4 GE-IR 450 mg, Period 5 Oxy 20 mg, Period 6 Placebo	EFDACB Period 1 GE-IR 200 mg, Period 2 GE-IR 450 mg, Period 3 GE-IR 450 mg + 20 mg Oxy, Period 4 Placebo, Period 5 GE-IR 200 mg + Oxy 20 mg, Period 6 Oxy 20 mg	FAEBDC Period 1 GE-IR 450 mg, Period 2 Placebo, Period 3 GE-IR 200 mg, Period 4 Oxy 20 mg, Period 5 GE-IR 450 mg + 20 mg Oxy, Period 6 GE-IR 200 mg + Oxy 20 mg
Washout From 2nd Dose (3 Days) Withdrawal by Subject	1	0	0	0	0	0
Washout From 2nd Dose (3 Days) Physician Decision	0	0	0	1	0	0
Washout of Third Dose (3 Days) Withdrawal by Subject	1	0	0	0	0	0
Washout of Fourth Dose (3 Days) Physician Decision	0	0	0	1	0	0
Washout of 5th Dose (3 Days) Pregnancy	0	0	0	0	0	1
Washout of 5th Dose (3 Days) Withdrawal by Subject	0	1	1	0	0	1
Washout of 5th Dose (3 Days) Adverse Event	0	0	0	0	0	1

Baseline Characteristics

Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users

Baseline characteristics by cohort

Measure	Subjects Eligible for Treatment Phase n=63 Participants Subjects that met all eligibility and qualification criteria and entered the study treatment phase.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	51 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants
Opioid Use in the Past 12 Months	12 uses n=5 Participants

PRIMARY outcome

Timeframe: approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase

Mean difference in Drug Liking Emax over 24 hours for Drug Liking ("At this moment, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.

Outcome measures

Measure	Placebo n=54 Participants oral masked Placebo Placebo: Participant will receive oral dose of placebo.	Oxycodone 20 mg n=54 Participants oral active control Oxycodone 20 mg: Participant will receive oral dose of oxycodone 20 mg.	GE-IR 200mg n=54 Participants single oral dose GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg n=54 Participants single oral dose GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.	GE-IR 200 mg + Oxycodone 20 mg n=54 Participants oral doses given together : Participant will receive oral dose of oxycodone 20 mg. GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg + Oxycodone 20 mg n=54 Participants oral doses given together Participant will receive oral dose of oxycodone 20 mg. GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.
Drug Liking Visual Analog Scale (VAS)	56.4 score on a scale Standard Error 1.75	84.9 score on a scale Standard Error 2.08	59.6 score on a scale Standard Error 2.28	64.6 score on a scale Standard Error 2.45	84.5 score on a scale Standard Error 2.11	86.6 score on a scale Standard Error 2.03

SECONDARY outcome

Timeframe: Approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase

Mean difference in Emax for Overall Drug Liking ("Overall, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.

Outcome measures

Measure	Placebo n=54 Participants oral masked Placebo Placebo: Participant will receive oral dose of placebo.	Oxycodone 20 mg n=54 Participants oral active control Oxycodone 20 mg: Participant will receive oral dose of oxycodone 20 mg.	GE-IR 200mg n=54 Participants single oral dose GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg n=54 Participants single oral dose GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.	GE-IR 200 mg + Oxycodone 20 mg n=54 Participants oral doses given together : Participant will receive oral dose of oxycodone 20 mg. GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg + Oxycodone 20 mg n=54 Participants oral doses given together Participant will receive oral dose of oxycodone 20 mg. GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.
Overall Drug Liking VAS	60.3 score on a scale Standard Error 2.33	85.6 score on a scale Standard Error 2.08	57.5 score on a scale Standard Error 2.03	65.2 score on a scale Standard Error 2.66	82.4 score on a scale Standard Error 2.51	84.5 score on a scale Standard Error 2.66

SECONDARY outcome

Timeframe: Approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase

Mean difference in Emax for Take Drug Again ("I would take this drug again"), assessed on a bipolar (0 to 100 points; 0: Definitely would not 50: Neither would nor would not, 100: Definitely would) VAS.

Outcome measures

Measure	Placebo n=54 Participants oral masked Placebo Placebo: Participant will receive oral dose of placebo.	Oxycodone 20 mg n=54 Participants oral active control Oxycodone 20 mg: Participant will receive oral dose of oxycodone 20 mg.	GE-IR 200mg n=54 Participants single oral dose GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg n=54 Participants single oral dose GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.	GE-IR 200 mg + Oxycodone 20 mg n=54 Participants oral doses given together : Participant will receive oral dose of oxycodone 20 mg. GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg + Oxycodone 20 mg n=54 Participants oral doses given together Participant will receive oral dose of oxycodone 20 mg. GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.
Take Drug Again VAS	60.8 score on a scale Standard Error 2.47	85.9 score on a scale Standard Error 2.25	56.7 score on a scale Standard Error 2.23	65.9 score on a scale Standard Error 2.69	85.2 score on a scale Standard Error 2.41	85.9 score on a scale Standard Error 2.67

SECONDARY outcome

Timeframe: within 1 hour prior to and approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase

Mean difference in Emax for High ("At this moment, I'm feeling high"), assessed on a unipolar (0 to 100 points; 0: Not at all, 100: Extremely) VAS.

Outcome measures

Measure	Placebo n=54 Participants oral masked Placebo Placebo: Participant will receive oral dose of placebo.	Oxycodone 20 mg n=54 Participants oral active control Oxycodone 20 mg: Participant will receive oral dose of oxycodone 20 mg.	GE-IR 200mg n=54 Participants single oral dose GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg n=54 Participants single oral dose GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.	GE-IR 200 mg + Oxycodone 20 mg n=54 Participants oral doses given together : Participant will receive oral dose of oxycodone 20 mg. GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg + Oxycodone 20 mg n=54 Participants oral doses given together Participant will receive oral dose of oxycodone 20 mg. GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.
High VAS	8.6 score on a scale Standard Error 2.72	66.3 score on a scale Standard Error 4.20	10.5 score on a scale Standard Error 3.24	20.1 score on a scale Standard Error 4.00	65.1 score on a scale Standard Error 4.02	73.2 score on a scale Standard Error 3.46

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Oxycodone 20 mg

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

GE-IR 200mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

GE-IR 450 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

GE-IR 200 mg + Oxycodone 20 mg

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

GE-IR 450 mg + Oxycodone 20 mg

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=61 participants at risk oral masked Placebo Placebo: Participant will receive oral dose of placebo.	Oxycodone 20 mg n=61 participants at risk oral active control Oxycodone 20 mg: Participant will receive oral dose of oxycodone 20 mg.	GE-IR 200mg n=60 participants at risk single oral dose GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg n=60 participants at risk single oral dose GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.	GE-IR 200 mg + Oxycodone 20 mg n=57 participants at risk oral doses given together : Participant will receive oral dose of oxycodone 20 mg. GE-IR 200 mg: Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	GE-IR 450 mg + Oxycodone 20 mg n=61 participants at risk oral doses given together Participant will receive oral dose of oxycodone 20 mg. GE-IR 450 mg: Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.
Psychiatric disorders Euphoric Mood	3.3% 2/61 • Number of events 2 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	16.4% 10/61 • Number of events 10 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	3.3% 2/60 • Number of events 2 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	11.7% 7/60 • Number of events 7 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	19.3% 11/57 • Number of events 11 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	31.1% 19/61 • Number of events 19 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Nervous system disorders Somnolence	9.8% 6/61 • Number of events 6 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	6.6% 4/61 • Number of events 4 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.7% 1/60 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	5.0% 3/60 • Number of events 3 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	14.0% 8/57 • Number of events 8 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	18.0% 11/61 • Number of events 11 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Nervous system disorders headache	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	3.3% 2/61 • Number of events 3 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.7% 1/60 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	8.3% 5/60 • Number of events 5 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	5.3% 3/57 • Number of events 3 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Skin and subcutaneous tissue disorders puritis	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	8.2% 5/61 • Number of events 5 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	12.3% 7/57 • Number of events 7 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	4.9% 3/61 • Number of events 3 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Gastrointestinal disorders Nausea	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	5.3% 3/57 • Number of events 3 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	6.6% 4/61 • Number of events 4 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Gastrointestinal disorders vomiting	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	3.3% 2/61 • Number of events 2 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Psychiatric disorders Anxiety	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Psychiatric disorders bradyphrenia	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Psychiatric disorders Emotional Disorder	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Psychiatric disorders Irritability	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Nervous system disorders dizzyness	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.7% 1/60 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Nervous system disorders lethargy	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Skin and subcutaneous tissue disorders dermatitis contact	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.7% 1/60 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Skin and subcutaneous tissue disorders skin mass	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.7% 1/60 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Gastrointestinal disorders abdominal pain	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Gastrointestinal disorders constipation	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 2 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Gastrointestinal disorders flatulence	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.7% 1/60 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Gastrointestinal disorders toothache	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
General disorders Feeling of Relaxation	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
General disorders Fatigue	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
General disorders Feeling Hot	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	3.3% 2/61 • Number of events 2 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
General disorders discomfort	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
General disorders Feeling abnormal	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.7% 1/60 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
General disorders Noncardiac Chestpain	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Musculoskeletal and connective tissue disorders backpain	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Musculoskeletal and connective tissue disorders muscle spasms	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Infections and infestations upper respiratory tract infection	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Eye disorders blurred vision	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Immune system disorders anaphylactoid reaction	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Injury, poisoning and procedural complications ligament sprain	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.7% 1/60 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Respiratory, thoracic and mediastinal disorders hiccups	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Vascular disorders hot flush	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Infections and infestations viral infection	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Eye disorders visual impairment	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/57 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.6% 1/61 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Musculoskeletal and connective tissue disorders musculoskeletal chest pain	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).
Musculoskeletal and connective tissue disorders musculoskeletal pain	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/60 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	1.8% 1/57 • Number of events 1 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).	0.00% 0/61 • AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).

Additional Information

Vice President of Clinical Development

Azurity Pharmaceuticals, Inc.

Phone: (913) 389-7961

Email: david.sequeira@azurity.com

Results disclosure agreements

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