Trial Outcomes & Findings for Symptomatic Management of Lyme Arthritis (NCT NCT04038346)

Results Overview

0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

days 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected

Results posted on

2025-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	NSAID Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

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	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only	Total n=3 Participants Total of all reporting groups
Sex: Female, Male Male	0 Participants n=1 Participants	1 Participants n=2 Participants	—	—	1 Participants n=3 Participants
Age, Categorical <=18 years	1 Participants n=1 Participants	2 Participants n=2 Participants	0 Participants	0 Participants	3 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants	0 Participants	0 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants	0 Participants	0 Participants n=3 Participants
Age, Continuous	9 years n=1 Participants	6 years n=2 Participants	—	—	7 years n=3 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	1 Participants n=2 Participants	—	—	2 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: days 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected

Population: VAS score for pain across all groups

0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys Day 7	0 score on a scale Interval 0.0 to 0.0	—	—	—
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys Day 10	0 score on a scale Interval 0.0 to 0.0	—	—	—
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys Day 14	—	20 score on a scale Interval 20.0 to 20.0	—	—
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys Day 21	0 score on a scale Interval 0.0 to 0.0	—	—	—
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys Day 28	0 score on a scale Interval 0.0 to 0.0	—	—	—
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys Day 1	50 score on a scale Interval 50.0 to 50.0	49.5 score on a scale Interval 49.0 to 50.0	—	—
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys Enrollment, Day 0	62 score on a scale Interval 62.0 to 62.0	58 score on a scale Interval 58.0 to 58.0	—	—
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys Day 3	16 score on a scale Interval 16.0 to 16.0	26 score on a scale Interval 26.0 to 26.0	—	—

PRIMARY outcome

Timeframe: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for join redness will be collected

Population: There was not 100% follow-up with text surveys

0-100 scale (no redness to maximal redness- higher score, worse outcome), slide bar in text survey

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys Enrollment, Day 0	61 score on a scale Interval 61.0 to 61.0	20 score on a scale Interval 20.0 to 20.0	—	—
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys Day 1	38 score on a scale Interval 38.0 to 38.0	22.5 score on a scale Interval 12.0 to 33.0	—	—
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys Day 3	7 score on a scale Interval 7.0 to 7.0	19 score on a scale Interval 19.0 to 19.0	—	—
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys Day 7	0 score on a scale Interval 0.0 to 0.0	—	—	—
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys Day 14	—	0 score on a scale Interval 0.0 to 0.0	—	—
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys Day 21	0 score on a scale Interval 0.0 to 0.0	—	—	—
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys Day 28	0 score on a scale Interval 0.0 to 0.0	—	—	—

PRIMARY outcome

Timeframe: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for joint movement will be collected

Population: Not all text survey instances completed.

0-100 scale (no joint movement to normal joint movement- higher score, better outcome), slide bar in text survey

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys Enrollment, Day 0	35 score on a scale Interval 35.0 to 35.0	50 score on a scale Interval 50.0 to 50.0	—	—
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys Day 1	50 score on a scale Interval 50.0 to 50.0	47 score on a scale Interval 37.0 to 57.0	—	—
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys Day 3	86 score on a scale Interval 86.0 to 86.0	78 score on a scale Interval 78.0 to 78.0	—	—
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys Day 7	100 score on a scale Interval 100.0 to 100.0	—	—	—
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys Day 14	—	84 score on a scale Interval 84.0 to 84.0	—	—
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys Day 21	100 score on a scale Interval 100.0 to 100.0	—	—	—
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys Day 28	100 score on a scale Interval 100.0 to 100.0	—	—	—

PRIMARY outcome

Timeframe: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected

Population: Not all text surveys completed.

0-100 scale (severely impaired function to normal function- higher score, better outcome), slide bar in text survey

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys Enrollment, Day 0	50 score on a scale Interval 50.0 to 50.0	50 score on a scale Interval 50.0 to 50.0	—	—
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys Day 1	65 score on a scale Interval 65.0 to 65.0	55.5 score on a scale Interval 50.0 to 61.0	—	—
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys Day 3	85 score on a scale Interval 85.0 to 85.0	89 score on a scale Interval 89.0 to 89.0	—	—
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys Day 7	100 score on a scale Interval 100.0 to 100.0	—	—	—
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys Day 10	100 score on a scale Interval 100.0 to 100.0	—	—	—
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys Day 14	—	83 score on a scale Interval 83.0 to 83.0	—	—
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys Day 21	100 score on a scale Interval 100.0 to 100.0	—	—	—
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys Day 28	100 score on a scale Interval 100.0 to 100.0	—	—	—

PRIMARY outcome

Timeframe: Symptom resolution recorded (days 0, 1, 3, 7, 10, 14, 21, 28, 60) once they enter "yes" to symptoms completely resolved

Population: 3 enrolled patients - none of the acetaminophen patients continued until resolution

If patient answers yes to symptoms completely resolved, the time frame from enrollment will be the days to symptom resolution

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
Time to Complete Symptom Resolution as Collected by a Yes/no Question on the Text Survey	6 days since enrollment Interval 6.0 to 6.0	—	—	—

SECONDARY outcome

Timeframe: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Population: Randomized participants, report percentage of medication doses taken that were available. (while still reporting symptoms)

Parents enter number of days patient has taken the medication in the past day as well as per day since the last survey in two questions on the text survey with their response being a drop down number list on the text survey- medication compliance will be compared to the number of doses that would be full compliance for that treatment arm

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
Medication Compliance as Determined by Question in Serial Text Survey Day 1	100 percentage of available med doses taken Interval 100.0 to 100.0	75 percentage of available med doses taken Interval 75.0 to 75.0	—	—
Medication Compliance as Determined by Question in Serial Text Survey Day 3	100 percentage of available med doses taken Interval 100.0 to 100.0	100 percentage of available med doses taken Interval 100.0 to 100.0	—	—
Medication Compliance as Determined by Question in Serial Text Survey Day 7	100 percentage of available med doses taken Interval 100.0 to 100.0	—	—	—
Medication Compliance as Determined by Question in Serial Text Survey Day 10	100 percentage of available med doses taken Interval 100.0 to 100.0	—	—	—
Medication Compliance as Determined by Question in Serial Text Survey Day 14	—	25 percentage of available med doses taken Interval 25.0 to 25.0	—	—

SECONDARY outcome

Timeframe: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Population: Randomized patients

survey asks parents to describe any medication side effects they feel their child has had - descriptive outcome only

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey Day 1	0 Participants	0 Participants	—	—
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey Day 3	0 Participants	0 Participants	—	—
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey Day 7	1 Participants	—	—	—
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey Day 10	0 Participants	—	—	—
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey Day 14	—	0 Participants	—	—
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey Day 21	0 Participants	—	—	—
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey Day 28	0 Participants	—	—	—

SECONDARY outcome

Timeframe: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Population: randomized participants

Parents are asked to list any medications in addition to their study drug and the prescribed antibiotic that their child has taken- descriptive outcome only

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey Day 1	0 Participants	0 Participants	—	—
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey Day 3	0 Participants	0 Participants	—	—
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey Day 7	0 Participants	—	—	—
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey Day 10	0 Participants	—	—	—
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey Day 14	—	0 Participants	—	—
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey Day 21	0 Participants	—	—	—
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey Day 28	0 Participants	—	—	—

SECONDARY outcome

Timeframe: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Population: All enrolled patients

Parents are asked if their child had fever in the 24 hours prior to taking the text survey

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey Day 0 (Enrollment)	1 Participants	0 Participants	—	—
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey Day 1	0 Participants	1 Participants	—	—
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey Day 3	0 Participants	0 Participants	—	—
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey Day 7	0 Participants	—	—	—
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey Day 10	0 Participants	—	—	—
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey Day 14	—	0 Participants	—	—
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey Day 21	0 Participants	—	—	—
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey Day 28	0 Participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 60 days, 120 days, 1 year

Population: All patients were analyzed for return visits by: 30 days, 60 days, 120 days, 1 year

Mean repeat medical visits for Lyme arthritis will be compared between treatment arms based on medical record review

Outcome measures

Outcome measures
Measure	NSAID n=1 Participants Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 Participants Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame 30 days	0 return visits for Lyme arthritis symptom Interval 0.0 to 0.0	0 return visits for Lyme arthritis symptom Interval 0.0 to 0.0	—	—
Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame 60 days	0 return visits for Lyme arthritis symptom Interval 0.0 to 0.0	0 return visits for Lyme arthritis symptom Interval 0.0 to 0.0	—	—
Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame 120 days	0 return visits for Lyme arthritis symptom Interval 0.0 to 0.0	0 return visits for Lyme arthritis symptom Interval 0.0 to 0.0	—	—
Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame 1 year	0 return visits for Lyme arthritis symptom Interval 0.0 to 0.0	0 return visits for Lyme arthritis symptom Interval 0.0 to 0.0	—	—

Adverse Events

NSAID

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NSAID First, Then Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NSAID n=1 participants at risk Naproxen at weight based standard dose given bid daily until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen)	Acetaminophen n=2 participants at risk Acetaminophen at weight based standard dose given qid until symptoms resolve Acetaminophen: Patients will be randomized to acetaminophen	NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Naproxen: Patients will be randomized to an NSAID (naproxen) Acetaminophen: Patients will be randomized to acetaminophen	Standard Care Symptom observation only
Gastrointestinal disorders Emesis	100.0% 1/1 • Number of events 1 • Collected by text surveys at days from enrollment: 0, 1, 3, 7, 10, 14, 21, 28, 60 until asymptomatic. Collected by text surveys at days from enrollment: 0, 1, 3, 7, 10, 14, 21, 28, 60. Question: Have you noticed any medication side-effects.	0.00% 0/2 • Collected by text surveys at days from enrollment: 0, 1, 3, 7, 10, 14, 21, 28, 60 until asymptomatic. Collected by text surveys at days from enrollment: 0, 1, 3, 7, 10, 14, 21, 28, 60. Question: Have you noticed any medication side-effects.	— 0/0 • Collected by text surveys at days from enrollment: 0, 1, 3, 7, 10, 14, 21, 28, 60 until asymptomatic. Collected by text surveys at days from enrollment: 0, 1, 3, 7, 10, 14, 21, 28, 60. Question: Have you noticed any medication side-effects.	— 0/0 • Collected by text surveys at days from enrollment: 0, 1, 3, 7, 10, 14, 21, 28, 60 until asymptomatic. Collected by text surveys at days from enrollment: 0, 1, 3, 7, 10, 14, 21, 28, 60. Question: Have you noticed any medication side-effects.

Additional Information

Desiree Neville

University of Pittsburgh Children's Hospital of Pittsburgh

Phone: 412-692-7692

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place