Trial Outcomes & Findings for Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence (NCT NCT05487456)

NCT ID: NCT05487456

Last Updated: 2024-03-13

Results Overview

To measure change in 3-hydroxypropyl mercapturic acid (3-HPMA), which is a biomarker of exposure to Acrolein.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: From baseline to 5 days
• Results posted on: 2024-03-13

Participant Flow

Participant milestones

Measure	P4M3 CA35 Ad libitum use of P4M3 using CA35 Cartridges P4M3 CA35: Ad libitum use of P4M3 with CA35 cartridges	P4M3 CM35 Ad libitum use of P4M3 using CM35 Cartridges P4M3 CM35: Ad libitum use of P4M3 with CM35 cartridges	Cigarette Ad libitum use of subject's own preferred CIG brand CIG: Ad libitum use of subject's own preferred brand of cigarettes	Smoking Abstinence Smoking abstinence Smoking Abstinence: Abstention from cigarette smoking
Overall Study STARTED	16	17	18	17
Overall Study COMPLETED	16	17	17	17
Overall Study NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Measure	P4M3 CA35 Ad libitum use of P4M3 using CA35 Cartridges P4M3 CA35: Ad libitum use of P4M3 with CA35 cartridges	P4M3 CM35 Ad libitum use of P4M3 using CM35 Cartridges P4M3 CM35: Ad libitum use of P4M3 with CM35 cartridges	Cigarette Ad libitum use of subject's own preferred CIG brand CIG: Ad libitum use of subject's own preferred brand of cigarettes	Smoking Abstinence Smoking abstinence Smoking Abstinence: Abstention from cigarette smoking
Overall Study Withdrawal by Subject	0	0	1	0

Baseline Characteristics

Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence

Baseline characteristics by cohort

Measure	P4M3 CA35 n=16 Participants Ad libitum use of P4M3 using CA35 Cartridges P4M3 CA35: Ad libitum use of P4M3 with CA35 cartridges	P4M3 CM35 n=17 Participants Ad libitum use of P4M3 using CM35 Cartridges P4M3 CM35: Ad libitum use of P4M3 with CM35 cartridges	Cigarette n=18 Participants Ad libitum use of subject's own preferred CIG brand CIG: Ad libitum use of subject's own preferred brand of cigarettes	Smoking Abstinence n=17 Participants Smoking abstinence Smoking Abstinence: Abstention from cigarette smoking	Enrolled But Not Randomized n=6 Participants Subjects enrolled in the study but not randomized.	Total n=74 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 11.69 • n=5 Participants	40.3 years STANDARD_DEVIATION 11.49 • n=7 Participants	39.8 years STANDARD_DEVIATION 11.75 • n=5 Participants	38.6 years STANDARD_DEVIATION 10.03 • n=4 Participants	39.7 years STANDARD_DEVIATION 10.07 • n=21 Participants	39.6 years STANDARD_DEVIATION 10.89 • n=10 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	0 Participants n=21 Participants	31 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	6 Participants n=21 Participants	43 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	17 Participants n=7 Participants	18 Participants n=5 Participants	17 Participants n=4 Participants	6 Participants n=21 Participants	73 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
BMI at admission	25.46 kg/m² STANDARD_DEVIATION 2.316 • n=5 Participants	25.74 kg/m² STANDARD_DEVIATION 3.486 • n=7 Participants	24.98 kg/m² STANDARD_DEVIATION 2.963 • n=5 Participants	24.54 kg/m² STANDARD_DEVIATION 2.769 • n=4 Participants	26.12 kg/m² STANDARD_DEVIATION 1.513 • n=21 Participants	25.25 kg/m² STANDARD_DEVIATION 2.812 • n=10 Participants

PRIMARY outcome

Timeframe: From baseline to 5 days

Population: Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

To measure change in 3-hydroxypropyl mercapturic acid (3-HPMA), which is a biomarker of exposure to Acrolein.

Outcome measures

Measure	P4M3 CA35 n=16 Participants Ad libitum use of P4M3 using CA35 Cartridges P4M3 CA35: Ad libitum use of P4M3 with CA35 cartridges	P4M3 CM35 n=16 Participants Ad libitum use of P4M3 using CM35 Cartridges P4M3 CM35: Ad libitum use of P4M3 with CM35 cartridges	Cigarette n=18 Participants Ad libitum use of subject's own preferred CIG brand CIG: Ad libitum use of subject's own preferred brand of cigarettes	Smoking Abstinence n=16 Participants Smoking abstinence Smoking Abstinence: Abstention from cigarette smoking
3-HPMA Baseline	657.46 ng/mg creatinine Interval 469.82 to 920.03	726.84 ng/mg creatinine Interval 536.06 to 985.51	703.29 ng/mg creatinine Interval 544.68 to 908.1	724.06 ng/mg creatinine Interval 516.52 to 1015.0
3-HPMA After 1 day of exposure	154.27 ng/mg creatinine Interval 120.24 to 197.92	155.85 ng/mg creatinine Interval 131.79 to 184.3	638.77 ng/mg creatinine Interval 486.69 to 838.37	149.66 ng/mg creatinine Interval 121.66 to 184.11
3-HPMA After 2 days of exposure	171.00 ng/mg creatinine Interval 144.04 to 203.0	167.93 ng/mg creatinine Interval 141.24 to 199.66	794.49 ng/mg creatinine Interval 621.7 to 1015.29	147.57 ng/mg creatinine Interval 119.15 to 182.76
3-HPMA After 3 days of exposure	112.48 ng/mg creatinine Interval 91.31 to 138.56	109.29 ng/mg creatinine Interval 97.88 to 122.02	670.16 ng/mg creatinine Interval 496.06 to 905.36	93.16 ng/mg creatinine Interval 82.69 to 104.96
3-HPMA After 4 days of exposure	194.46 ng/mg creatinine Interval 155.93 to 242.5	241.24 ng/mg creatinine Interval 189.75 to 306.7	728.51 ng/mg creatinine Interval 549.25 to 966.27	189.48 ng/mg creatinine Interval 154.44 to 232.46
3-HPMA After 5 days of exposure	105.20 ng/mg creatinine Interval 90.85 to 121.83	111.12 ng/mg creatinine Interval 89.54 to 137.9	544.77 ng/mg creatinine Interval 373.74 to 794.07	93.20 ng/mg creatinine Interval 81.69 to 106.34

PRIMARY outcome

Timeframe: From baseline to 5 days

Population: Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

To measure change in 2-cyanoethyl mercapturic acid (2-CyEMA), which is a biomarker of exposure to Acrylonitrile.

Outcome measures

Measure	P4M3 CA35 n=16 Participants Ad libitum use of P4M3 using CA35 Cartridges P4M3 CA35: Ad libitum use of P4M3 with CA35 cartridges	P4M3 CM35 n=16 Participants Ad libitum use of P4M3 using CM35 Cartridges P4M3 CM35: Ad libitum use of P4M3 with CM35 cartridges	Cigarette n=18 Participants Ad libitum use of subject's own preferred CIG brand CIG: Ad libitum use of subject's own preferred brand of cigarettes	Smoking Abstinence n=16 Participants Smoking abstinence Smoking Abstinence: Abstention from cigarette smoking
2-CyEMA Baseline	97.17 ng/mg creatinine Interval 69.12 to 136.61	108.50 ng/mg creatinine Interval 81.79 to 143.92	98.85 ng/mg creatinine Interval 77.25 to 126.5	100.39 ng/mg creatinine Interval 70.02 to 143.92
2-CyEMA After 1 day of exposure	33.47 ng/mg creatinine Interval 22.35 to 50.12	37.47 ng/mg creatinine Interval 28.39 to 49.44	90.13 ng/mg creatinine Interval 69.22 to 117.34	33.68 ng/mg creatinine Interval 22.17 to 51.18
2-CyEMA After 2 days of exposure	17.99 ng/mg creatinine Interval 10.93 to 29.6	22.95 ng/mg creatinine Interval 17.71 to 29.75	100.04 ng/mg creatinine Interval 77.18 to 129.66	18.12 ng/mg creatinine Interval 10.05 to 32.66
2-CyEMA After 3 days of exposure	16.40 ng/mg creatinine Interval 9.08 to 29.61	20.06 ng/mg creatinine Interval 14.91 to 26.98	96.41 ng/mg creatinine Interval 71.29 to 130.38	15.67 ng/mg creatinine Interval 8.52 to 28.82
2-CyEMA After 4 days of exposure	12.79 ng/mg creatinine Interval 7.26 to 22.55	16.78 ng/mg creatinine Interval 12.7 to 22.19	85.54 ng/mg creatinine Interval 61.48 to 119.02	14.40 ng/mg creatinine Interval 8.08 to 25.64
2-CyEMA After 5 days of exposure	12.31 ng/mg creatinine Interval 6.81 to 22.25	17.09 ng/mg creatinine Interval 11.93 to 24.47	79.87 ng/mg creatinine Interval 54.04 to 118.05	12.95 ng/mg creatinine Interval 7.02 to 23.87

PRIMARY outcome

Timeframe: From baseline to 5 days

Population: Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

To measure change in Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL), which is a biomarker of exposure to 4-(methylnitrosamino)-1-(3- pyridyl)-1-butanone (NNK).

Outcome measures

Measure	P4M3 CA35 n=16 Participants Ad libitum use of P4M3 using CA35 Cartridges P4M3 CA35: Ad libitum use of P4M3 with CA35 cartridges	P4M3 CM35 n=16 Participants Ad libitum use of P4M3 using CM35 Cartridges P4M3 CM35: Ad libitum use of P4M3 with CM35 cartridges	Cigarette n=18 Participants Ad libitum use of subject's own preferred CIG brand CIG: Ad libitum use of subject's own preferred brand of cigarettes	Smoking Abstinence n=16 Participants Smoking abstinence Smoking Abstinence: Abstention from cigarette smoking
Total NNAL Baseline	114.66 pg/mg creatinine Interval 71.39 to 184.15	145.13 pg/mg creatinine Interval 96.82 to 217.53	116.41 pg/mg creatinine Interval 78.3 to 173.06	115.95 pg/mg creatinine Interval 66.28 to 202.86
Total NNAL After 1 day of exposure	58.27 pg/mg creatinine Interval 32.64 to 104.03	85.16 pg/mg creatinine Interval 58.39 to 124.22	106.12 pg/mg creatinine Interval 69.17 to 162.81	68.39 pg/mg creatinine Interval 39.47 to 118.5
Total NNAL After 2 days of exposure	46.46 pg/mg creatinine Interval 26.01 to 82.96	63.61 pg/mg creatinine Interval 40.95 to 98.82	112.97 pg/mg creatinine Interval 75.73 to 168.53	44.14 pg/mg creatinine Interval 20.37 to 95.65
Total NNAL After 3 days of exposure	42.80 pg/mg creatinine Interval 22.5 to 81.41	59.25 pg/mg creatinine Interval 36.83 to 95.32	111.82 pg/mg creatinine Interval 74.08 to 168.79	40.39 pg/mg creatinine Interval 20.14 to 80.99
Total NNAL After 4 days of exposure	36.24 pg/mg creatinine Interval 19.6 to 66.99	51.10 pg/mg creatinine Interval 32.64 to 80.02	102.41 pg/mg creatinine Interval 66.16 to 158.52	37.82 pg/mg creatinine Interval 18.68 to 76.57
Total NNAL After 5 days of exposure	32.73 pg/mg creatinine Interval 17.63 to 60.78	53.87 pg/mg creatinine Interval 32.16 to 90.23	101.05 pg/mg creatinine Interval 64.72 to 157.78	37.94 pg/mg creatinine Interval 18.91 to 76.12

PRIMARY outcome

Timeframe: From baseline to 5 days

Population: Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

To measure change in carboxyhemoglobin (COHb), which is a biomarker of exposure to Carbon monoxide (CO).

Outcome measures

Measure	P4M3 CA35 n=16 Participants Ad libitum use of P4M3 using CA35 Cartridges P4M3 CA35: Ad libitum use of P4M3 with CA35 cartridges	P4M3 CM35 n=16 Participants Ad libitum use of P4M3 using CM35 Cartridges P4M3 CM35: Ad libitum use of P4M3 with CM35 cartridges	Cigarette n=18 Participants Ad libitum use of subject's own preferred CIG brand CIG: Ad libitum use of subject's own preferred brand of cigarettes	Smoking Abstinence n=16 Participants Smoking abstinence Smoking Abstinence: Abstention from cigarette smoking
COHb Baseline	2.99 percent saturation of hemoglobin Interval 2.53 to 3.53	2.91 percent saturation of hemoglobin Interval 2.38 to 3.54	2.58 percent saturation of hemoglobin Interval 2.36 to 2.83	2.71 percent saturation of hemoglobin Interval 2.4 to 3.07
COHb After 1 day of exposure	3.06 percent saturation of hemoglobin Interval 2.6 to 3.6	3.10 percent saturation of hemoglobin Interval 2.45 to 3.92	2.69 percent saturation of hemoglobin Interval 2.47 to 2.93	2.96 percent saturation of hemoglobin Interval 2.56 to 3.43
COHb After 2 days of exposure	1.71 percent saturation of hemoglobin Interval 1.58 to 1.86	1.80 percent saturation of hemoglobin Interval 1.52 to 2.13	2.87 percent saturation of hemoglobin Interval 2.64 to 3.12	1.64 percent saturation of hemoglobin Interval 1.55 to 1.75
COHb After 3 days of exposure	1.55 percent saturation of hemoglobin Interval 1.43 to 1.68	1.59 percent saturation of hemoglobin Interval 1.48 to 1.71	2.80 percent saturation of hemoglobin Interval 2.53 to 3.1	1.57 percent saturation of hemoglobin Interval 1.44 to 1.71
COHb After 4 days of exposure	1.64 percent saturation of hemoglobin Interval 1.39 to 1.95	1.69 percent saturation of hemoglobin Interval 1.38 to 2.07	2.72 percent saturation of hemoglobin Interval 2.44 to 3.03	1.45 percent saturation of hemoglobin Interval 1.33 to 1.57
COHb After 5 days of exposure	1.52 percent saturation of hemoglobin Interval 1.41 to 1.63	1.53 percent saturation of hemoglobin Interval 1.39 to 1.68	2.78 percent saturation of hemoglobin Interval 2.45 to 3.15	1.45 percent saturation of hemoglobin Interval 1.26 to 1.67

Adverse Events

P4M3 CA35

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

P4M3 CM35

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cigarette

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Smoking Abstinence

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Enrolled But Not Randomized

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	P4M3 CA35 n=16 participants at risk Ad libitum use of P4M3 using CA35 Cartridges P4M3 CA35: Ad libitum use of P4M3 with CA35 cartridges	P4M3 CM35 n=17 participants at risk Ad libitum use of P4M3 using CM35 Cartridges P4M3 CM35: Ad libitum use of P4M3 with CM35 cartridges	Cigarette n=18 participants at risk Ad libitum use of subject's own preferred CIG brand CIG: Ad libitum use of subject's own preferred brand of cigarettes	Smoking Abstinence n=17 participants at risk Smoking abstinence Smoking Abstinence: Abstention from cigarette smoking	Enrolled But Not Randomized n=6 participants at risk Subjects enrolled in the study but not randomized.
Nervous system disorders Headache	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	16.7% 3/18 • Number of events 3 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	11.8% 2/17 • Number of events 2 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	16.7% 1/6 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Nervous system disorders Dizziness	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.6% 1/18 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Gastrointestinal disorders Constipation	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.6% 1/18 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	11.8% 2/17 • Number of events 2 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Gastrointestinal disorders Nausea	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.6% 1/18 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Injury, poisoning and procedural complications Arthropod Sting	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/18 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/18 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
General disorders Pain	6.2% 1/16 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/18 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Reproductive system and breast disorders Dysmenorrhoea	6.2% 1/16 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/18 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/18 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/18 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/18 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.
Gastrointestinal disorders Abdominal pain	0.00% 0/16 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/17 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/18 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.	0.00% 0/6 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 38 days.

Additional Information

Christelle Haziza, Global Head Clinical Research and Execution

Philip Morris Products S.A.

Phone: +41 58 242 11 11

Email: ClinicalTrials.PMI@pmi.com

Results disclosure agreements

• Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements. The Intellectual Property rights and research results from the present study belong to the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER