Trial Outcomes & Findings for Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines (NCT NCT05146999)

Last Updated: 2024-10-21

Results Overview

Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded "improved," "much improved," or "very much improved" on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

132 participants

Primary outcome timeframe

At Month 1

Results posted on

2024-10-21

Participant Flow

This study was conducted at 9 investigational centers in the United States (US) from 09 May 2022 to 01 September 2023.

A total of 132 participants were enrolled and treated in this study.

Participant milestones

Participant milestones
Measure	Experimental: QM1114-DP Participants received a single dose of 50 U (0.5 mL) (Milliliter) QM1114-DP intramuscularly (IM), divided into 5 equal aliquots injected into the glabellar area (10 U \[0.1 mL\] per injection point).	Placebo Comparator: Placebo Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point).
Overall Study STARTED	99	33
Overall Study COMPLETED	89	27
Overall Study NOT COMPLETED	10	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: QM1114-DP Participants received a single dose of 50 U (0.5 mL) (Milliliter) QM1114-DP intramuscularly (IM), divided into 5 equal aliquots injected into the glabellar area (10 U \[0.1 mL\] per injection point).	Placebo Comparator: Placebo Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point).
Overall Study Withdrew consent	6	1
Overall Study Lost to Follow-up	3	2
Overall Study Other	1	3

Baseline Characteristics

Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: QM1114-DP n=99 Participants Participants received a single dose of 50 U (0.5 mL) QM1114-DP IM, divided into 5 equal aliquots injected into the glabellar area (10 U \[0.1 mL\] per injection point).	Placebo Comparator: Placebo n=33 Participants Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point).	Total n=132 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 10.72 • n=5 Participants	52.5 years STANDARD_DEVIATION 10.31 • n=7 Participants	52.2 years STANDARD_DEVIATION 10.58 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	31 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	13 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants	20 Participants n=7 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	92 Participants n=5 Participants	31 Participants n=7 Participants	123 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 1

Population: Intent to treat (ITT) population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme.

Outcome measures

Outcome measures
Measure	Experimental: QM1114-DP n=99 Participants Participants received a single dose of 50 U (0.5 mL) QM1114-DP IM, divided into 5 equal aliquots injected into the glabellar area (10 U \[0.1 mL\] per injection point).	Placebo Comparator: Placebo n=33 Participants Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point).
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1	92 Participants	3 Participants

SECONDARY outcome

Timeframe: At Days 0 through 7 post-treatment

Population: ITT population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme.

Following treatment at baseline, participants were asked to record their assessment of study treatment response in a diary card on Days 0 through 7. They were asked to respond "yes" or "no" to the following question: "Since being injected, have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows) when you frown?" Response to treatment effect given by a Participant on first day as "yes" to the diary question.

Outcome measures

Outcome measures
Measure	Experimental: QM1114-DP n=99 Participants Participants received a single dose of 50 U (0.5 mL) QM1114-DP IM, divided into 5 equal aliquots injected into the glabellar area (10 U \[0.1 mL\] per injection point).	Placebo Comparator: Placebo n=33 Participants Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point).
Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card	89 Participants	3 Participants

SECONDARY outcome

Timeframe: From Day 1 through Month 12

Population: ITT population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. Here, "number analyzed" signifies participants in total observed cases at given time points.

Participant assessment From Day 1 through Month 12 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a Participant who responded "improved," "much improved," or "very much improved" on the GAIS at maximum frown. This analysis is based on observed cases.

Outcome measures

Outcome measures
Measure	Experimental: QM1114-DP n=99 Participants Participants received a single dose of 50 U (0.5 mL) QM1114-DP IM, divided into 5 equal aliquots injected into the glabellar area (10 U \[0.1 mL\] per injection point).	Placebo Comparator: Placebo n=33 Participants Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point).
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Day 1	39 participants Interval 30.1 to 49.49	4 participants Interval 0.99 to 23.26
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Day 2	66 participants Interval 58.06 to 76.63	4 participants Interval 1.04 to 23.96
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Day 3	79 participants Interval 73.71 to 89.18	4 participants Interval 1.1 to 24.7
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Day 4	87 participants Interval 84.79 to 96.46	4 participants Interval 1.1 to 24.7
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Month 1	92 participants Interval 89.13 to 98.62	3 participants Interval 0.0 to 20.08
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Month 3	87 participants Interval 82.53 to 95.03	1 participants Interval 0.0 to 9.76
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Month 6	64 participants Interval 58.66 to 77.51	1 participants Interval 0.0 to 9.76
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Month 7	51 participants Interval 45.85 to 66.24	1 participants Interval 0.0 to 10.09
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Month 8	45 participants Interval 39.18 to 59.72	1 participants Interval 0.0 to 10.83
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Month 9	38 participants Interval 32.42 to 52.97	1 participants Interval 0.0 to 10.83
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Month 10	32 participants Interval 26.99 to 47.43	0 participants Interval 0.0 to 0.0
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Month 11	31 participants Interval 25.9 to 46.19	0 participants Interval 0.0 to 0.0
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 Month 12	34 participants Interval 27.76 to 47.79	1 participants Interval 0.0 to 10.09

Adverse Events

Experimental: QM1114-DP

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo Comparator: Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Felipe Weinberg, MD, MPH

Galderma Research & Development, LLC

Phone: 817-961-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Experimental: QM1114-DP n=99 participants at risk Participants received a single dose of 50 U (0.5 mL) QM1114-DP IM, divided into 5 equal aliquots injected into the glabellar area (10 U \[0.1 mL\] per injection point).	Placebo Comparator: Placebo n=33 participants at risk Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point).
Infections and infestations COVID-19	7.1% 7/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	9.1% 3/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Upper respiratory tract infection	4.0% 4/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	6.1% 2/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Sinusitis	3.0% 3/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Procedural pain	3.0% 3/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Contusion	2.0% 2/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Fall	2.0% 2/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Nervous system disorders Headache	6.1% 6/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	4.0% 4/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
General disorders Injection site bruising	2.0% 2/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Skin and subcutaneous tissue disorders Dermatitis contact	2.0% 2/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Conjunctivitis bacterial	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Gastroenteritis viral	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Hordeolum	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Influenza	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Postoperative wound infection	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Tonsillitis	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Wound infection	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Conjunctivitis	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Infections and infestations Gastroenteritis	0.00% 0/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Hand fracture	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Limb injury	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Muscle strain	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Rib fracture	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Skin laceration	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Tooth fracture	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Injury, poisoning and procedural complications Wrist fracture	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Nervous system disorders Tension headache	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Nervous system disorders Transient ischaemic attack	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Nervous system disorders Migraine	0.00% 0/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Gastrointestinal disorders Diarrhoea	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Gastrointestinal disorders Dyspepsia	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Gastrointestinal disorders Irritable bowel syndrome	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
General disorders Injection site pain	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Immune system disorders Drug hypersensitivity	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Renal and urinary disorders Hydronephrosis	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Renal and urinary disorders Ureterolithiasis	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	0.00% 0/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Vascular disorders Hypertension	1.0% 1/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Vascular disorders Aortic stenosis	0.00% 0/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Cardiac disorders Coronary artery disease	0.00% 0/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Investigations Blood cholesterol increased	0.00% 0/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Investigations Oxygen saturation decreased	0.00% 0/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/99 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.	3.0% 1/33 • From Day 1 up to end of study (Up to 12 Months) Safety population included all participants who were treated with QM1114-DP and Placebo.