Trial Outcomes & Findings for A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP) (NCT NCT03881007)

Last Updated: 2021-05-07

Results Overview

The sum of new diagnoses of Gonnorhea (Ng), Chlamydia (Ct) and syphilis in a 3 month period on LCM/placebo. Each participant can only contribute one diagnosis of Ct and one diagnosis of Ng per visit - regardless of number of sites infected. Thus each participant can contribute up to 3 diagnoses (Ct/Ng/syphilis) at each visit. The diagnosis of Ng and Ct will be made via molecular testing and syphilis via Rapid Plasma Reagin test (RPR) and Treponema Pallidum Antibodies tests (TPA) according to currently used European case definitions.

Recruitment status

TERMINATED

Study phase

Target enrollment

343 participants

Primary outcome timeframe

3-month period following each intervention

Results posted on

2021-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	LCM (Intervention), Then Placebo Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex for 3 months and after 3 months they will switch to the placebo.	Placebo, Then LCM (Intervention) Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex during 3 months and after 3 months they will switch to the LCM mouthwash.
First 3 Months STARTED	172	171
First 3 Months COMPLETED	121	119
First 3 Months NOT COMPLETED	51	52
Last 3 Months STARTED	121	119
Last 3 Months COMPLETED	77	74
Last 3 Months NOT COMPLETED	44	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LCM (Intervention), Then Placebo n=172 Participants Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex for 3 months and then switch to placebo mouthwash for 3 months.	Placebo, Then LCM n=171 Participants Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex for 3 months and then switch to LCM mouthwash for 3 months.	Total n=343 Participants Total of all reporting groups
Age, Continuous	39 years n=172 Participants	40 years n=171 Participants	40 years n=343 Participants
Sex: Female, Male Female	0 Participants n=172 Participants	0 Participants n=171 Participants	0 Participants n=343 Participants
Sex: Female, Male Male	172 Participants n=172 Participants	171 Participants n=171 Participants	343 Participants n=343 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Sexually Transmitted Infection (STI) history (last 24 months) Any STI	172 Participants n=172 Participants	171 Participants n=171 Participants	343 Participants n=343 Participants
Sexually Transmitted Infection (STI) history (last 24 months) Chlamydia	89 Participants n=172 Participants	82 Participants n=171 Participants	171 Participants n=343 Participants
Sexually Transmitted Infection (STI) history (last 24 months) Gonorrhea	100 Participants n=172 Participants	117 Participants n=171 Participants	217 Participants n=343 Participants
Sexually Transmitted Infection (STI) history (last 24 months) Syphilis	75 Participants n=172 Participants	66 Participants n=171 Participants	141 Participants n=343 Participants
Sexually Transmitted Infection (STI) history (last 24 months) Other	15 Participants n=172 Participants	21 Participants n=171 Participants	36 Participants n=343 Participants
Antibiotics use (last 6 months) Any antibiotics	140 Participants n=172 Participants	136 Participants n=171 Participants	276 Participants n=343 Participants
Antibiotics use (last 6 months) Macrolides	71 Participants n=172 Participants	86 Participants n=171 Participants	157 Participants n=343 Participants
Antibiotics use (last 6 months) Beta-lactam	111 Participants n=172 Participants	121 Participants n=171 Participants	232 Participants n=343 Participants
Antibiotics use (last 6 months) Fluoroquinolones	4 Participants n=172 Participants	3 Participants n=171 Participants	7 Participants n=343 Participants
Antibiotics use (last 6 months) Tetracyclines	47 Participants n=172 Participants	30 Participants n=171 Participants	77 Participants n=343 Participants
Antibiotics use (last 6 months) Other	0 Participants n=172 Participants	2 Participants n=171 Participants	2 Participants n=343 Participants
Number of main partners (last 3 months)	1 Main partners n=172 Participants	1 Main partners n=171 Participants	1 Main partners n=343 Participants
Number of casual partners (last 3 months)	10 casual partners n=172 Participants	10 casual partners n=171 Participants	10 casual partners n=343 Participants
Condom use with casual partners 0-24%	50 Participants n=172 Participants	62 Participants n=171 Participants	112 Participants n=343 Participants
Condom use with casual partners 25-49%	42 Participants n=172 Participants	34 Participants n=171 Participants	76 Participants n=343 Participants
Condom use with casual partners 50-74%	31 Participants n=172 Participants	26 Participants n=171 Participants	57 Participants n=343 Participants
Condom use with casual partners 75-100%	44 Participants n=172 Participants	42 Participants n=171 Participants	86 Participants n=343 Participants

PRIMARY outcome

Timeframe: 3-month period following each intervention

Population: Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).

Outcome measures

Outcome measures
Measure	LCM (Intervention) n=195 Participants Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex	Placebo n=196 Participants Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period First 3 months : Any STI	36 Participants	33 Participants
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period First 3 months : Chlamydia	19 Participants	18 Participants
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period First 3 months : Gonorrhea	19 Participants	17 Participants
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period First 3 months : Syphilis	2 Participants	6 Participants
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period Last 3 months : Any STI	27 Participants	21 Participants
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period Last 3 months : Chlamydia	11 Participants	10 Participants
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period Last 3 months : Gonorrhea	14 Participants	8 Participants
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period Last 3 months : Syphilis	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 3-month period following each intervention

Incidence rate of new pharyngeal Ng cases in each allocation arm for each study period of 3 months.

Outcome measures

Outcome measures
Measure	LCM (Intervention) n=195 Participants Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex	Placebo n=196 Participants Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex
Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period First 3 months	8 diagnoses	2 diagnoses
Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period Last 3 months	3 diagnoses	0 diagnoses

SECONDARY outcome

Timeframe: 3-month period following each intervention

Incidence rate of new Ct cases in each allocation arm (LCM and placebo) for each study period of 3 months.

Outcome measures

Outcome measures
Measure	LCM (Intervention) n=195 Participants Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex	Placebo n=196 Participants Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex
Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period First 3 months	19 diagnoses	18 diagnoses
Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period Last 3 months	11 diagnoses	10 diagnoses

SECONDARY outcome

Timeframe: 3-month period following each intervention

Incidence rate of new syphilis cases in each allocation arm (LCM and placebo) for each study period of 3 months.

Outcome measures

Outcome measures
Measure	LCM (Intervention) n=195 Participants Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex	Placebo n=196 Participants Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex
Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo First 3 months	2 diagnoses	6 diagnoses
Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo Last 3 months	4 diagnoses	4 diagnoses

SECONDARY outcome

Timeframe: 6-month period

Population: Intention-to-treat population.LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).

Daily: Proportion of days in study used mouthwash at least daily Post sex: Proportion of casual sexual contacts in study when mouthwash used post sex. Pre sex: proportion of casual sexual contacts in study when mouthwash used pre sex

Outcome measures

Outcome measures
Measure	LCM (Intervention) n=195 Participants Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex	Placebo n=196 Participants Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 daily use · 0-24%	11 Participants	14 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 daily use · 25-49%	8 Participants	9 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 daily use · 50-74%	17 Participants	14 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 daily use · 75-100%	80 Participants	79 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 daily use · Missing	5 Participants	3 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 daily use · 0-24%	6 Participants	6 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 daily use · 25-49%	4 Participants	5 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 daily use · 50-74%	9 Participants	11 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 daily use · 75-100%	15 Participants	9 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 daily use · Missing	40 Participants	46 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 pre-sex · 0-24%	30 Participants	36 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 pre-sex · 25-49%	15 Participants	18 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 pre-sex · 50-74%	20 Participants	19 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 pre-sex · 75-100%	49 Participants	41 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 pre-sex · Missing	7 Participants	5 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 pre-sex · 0-24%	19 Participants	13 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 pre-sex · 25-49%	13 Participants	15 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 pre-sex · 50-74%	13 Participants	18 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 pre-sex · 75-100%	25 Participants	24 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 pre-sex · Missing	4 Participants	7 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 post-sex · 0-24%	31 Participants	38 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 post-sex · 25-49%	16 Participants	16 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 post-sex · 50-74%	22 Participants	26 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 post-sex · 75-100%	45 Participants	34 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 3 post-sex · Missing	7 Participants	5 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 post-sex · 0-24%	22 Participants	14 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 post-sex · 25-49%	13 Participants	17 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 post-sex · 50-74%	14 Participants	18 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 post-sex · 75-100%	21 Participants	21 Participants
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex Month 6 post-sex · Missing	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 3-month period following each intervention

Incidence rate of Ng, Ct and syphilis between both groups (LCM and placebo) post controlling for adherence to mouthwash

Outcome measures

Outcome measures
Measure	LCM (Intervention) n=195 Participants Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex	Placebo n=196 Participants Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash Last 3 months: Any STI	27 Participants	21 Participants
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash Last 3 months: Chlamydia	11 Participants	10 Participants
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash Last 3 months: Gonorrhea	14 Participants	8 Participants
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash Last 3 months: Syphilis	4 Participants	4 Participants
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash First 3 months: Any STIs	36 Participants	33 Participants
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash First 3 months: Chlamydia	19 Participants	18 Participants
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash First 3 months: Gonorrhea	19 Participants	17 Participants
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash First 3 months: Syphilis	2 Participants	6 Participants

SECONDARY outcome

Timeframe: 3-month period following each intervention

Population: The overall number of participants analyzed is for both study periods. The number analyzed per row is the number of participants analyzed per period. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).

Cumulative number of antibiotics used between both groups (LCM and placebo) for each period

Outcome measures

Outcome measures
Measure	LCM (Intervention) n=195 Participants Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex	Placebo n=196 Participants Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex
Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo Month 3	49 Participants	55 Participants
Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo Month 6	39 Participants	35 Participants

Adverse Events

LCM (Intervention)

Serious events: 1 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LCM (Intervention) n=195 participants at risk Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex. The total of participants at risk for the LCM intervention is 195 (121 in first 3 months and 77 in last 3 months).	Placebo n=196 participants at risk Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex. The total of participants at risk for the LCM intervention is 196 (119 in first 3 months and 74 in last 3 months).
Infections and infestations Ludwig Angina	0.51% 1/195 • Number of events 1 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).	0.00% 0/196 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
Psychiatric disorders Suicidal depression	0.00% 0/195 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).	0.51% 1/196 • Number of events 1 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
Reproductive system and breast disorders Testis carcinoma	0.00% 0/195 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).	0.51% 1/196 • Number of events 1 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
Infections and infestations HIV	0.00% 0/195 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).	0.51% 1/196 • Number of events 1 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).

Other adverse events

Other adverse events
Measure	LCM (Intervention) n=195 participants at risk Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex. The total of participants at risk for the LCM intervention is 195 (121 in first 3 months and 77 in last 3 months).	Placebo n=196 participants at risk Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex. The total of participants at risk for the LCM intervention is 196 (119 in first 3 months and 74 in last 3 months).
Gastrointestinal disorders Dental caries	9.7% 19/195 • Number of events 19 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).	6.1% 12/196 • Number of events 12 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
Gastrointestinal disorders Tooth discoloration	13.3% 26/195 • Number of events 26 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).	9.2% 18/196 • Number of events 18 • Adverse events and serious adverse events were collected over the whole study duration (6 months) Adverse events are reported per intervention. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).

Additional Information

Dr. Chris Kenyon

Institute of Tropical Medicine Antwerp

Phone: +32(0)32470786

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place