Trial Outcomes & Findings for Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria (NCT NCT02802501)

Results Overview

A participant was considered to have demonstrated relapse-free efficacy at 6 months if: a) Participant had non-zero Plasmodium vivax (P.vivax) asexual parasite count at Baseline (Day 1), b) Participant demonstrated initial clearance of P.vivax parasitemia, c) Participant had no positive asexual P.vivax parasite count at any assessment prior to or on study Day 180 following initial parasite clearance, d) Participants did not take a concomitant medication with anti-malarial activity (excluding study treatment) at any point between Study Day 1 and their last parasite assessment, e) Participant was parasite-free at 6 months. The percentage of participants who were relapse-free at 6 months post dose has been presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

150 participants

Primary outcome timeframe

6 months post-dose

Results posted on

2020-07-24

Participant Flow

This was a single center randomized, double-blind, parallel group study to evaluate the efficacy and safety of tafenoquine co-administered with DHA-PQP for the radical cure of P.vivax malaria in Indonesian soldiers. Participants with microscopy-confirmed P.vivax were recruited at 2malaria-free bases in Java following deployment to Indonesian Papua.

A total of 164 participants were screened of whom 14 failed during screening and 150 were randomized to receive dihydroartemisinin-piperaquine (DHA-PQP) only, tafenoquine+DHA-PQP and primaquine+DHA-PQP in a ratio of 1:1:1.

Participant milestones

Participant milestones
Measure	DHA-PQP Only Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Double-blind (Up to Day 180) STARTED	50	50	50
Double-blind (Up to Day 180) COMPLETED	50	50	50
Double-blind (Up to Day 180) NOT COMPLETED	0	0	0
Open-Label (Day 180 to Day 195) STARTED	6	12	26
Open-Label (Day 180 to Day 195) COMPLETED	6	12	26
Open-Label (Day 180 to Day 195) NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Total n=150 Participants Total of all reporting groups
Age, Continuous	28.3 Years STANDARD_DEVIATION 4.34 • n=5 Participants	29.4 Years STANDARD_DEVIATION 5.10 • n=7 Participants	28.6 Years STANDARD_DEVIATION 5.56 • n=5 Participants	28.8 Years STANDARD_DEVIATION 5.01 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	50 Participants n=7 Participants	50 Participants n=5 Participants	150 Participants n=4 Participants
Race/Ethnicity, Customized ASIAN - SOUTH EAST ASIAN HERITAGE	50 Participants n=5 Participants	50 Participants n=7 Participants	50 Participants n=5 Participants	150 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months post-dose

Population: Microbiologic Intent-to-Treat (mITT) Population consisted of all randomized participants who received at least one dose of blinded study treatment and had microscopically confirmed P. vivax parasitamia at Baseline.

A participant was considered to have demonstrated relapse-free efficacy at 6 months if: a) Participant had non-zero Plasmodium vivax (P.vivax) asexual parasite count at Baseline (Day 1), b) Participant demonstrated initial clearance of P.vivax parasitemia, c) Participant had no positive asexual P.vivax parasite count at any assessment prior to or on study Day 180 following initial parasite clearance, d) Participants did not take a concomitant medication with anti-malarial activity (excluding study treatment) at any point between Study Day 1 and their last parasite assessment, e) Participant was parasite-free at 6 months. The percentage of participants who were relapse-free at 6 months post dose has been presented.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone	12 Percentage of participants	22 Percentage of participants	—

SECONDARY outcome

Timeframe: 6 months post-dose

Population: mITT Population.

A participant was considered to have demonstrated relapse-free efficacy at 6 months if: a) Participant had non-zero P. vivax asexual parasite count at Baseline (Day 1), b) Participant demonstrated initial clearance of P.vivax parasitemia, c) Participant had no positive asexual P.vivax parasite count at any assessment prior to or on study Day 180 following initial parasite clearance, d) Participants did not take a concomitant medication with anti-malarial activity (excluding study treatment) at any point between Study Day 1 and their last parasite assessment, e) Participant was parasite-free at 6 months. The percentage of participants who were relapse-free at 6 months post dose has been presented.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and Primaquine+DHA-PQP	22 Percentage of participants	52 Percentage of participants	—

SECONDARY outcome

Timeframe: 6 months post-dose

Population: mITT Population.

A participant was considered to have demonstrated relapse-free efficacy at 6 months if: a) Participant had non-zero P. vivax asexual parasite count at Baseline (Day 1), b) Participant demonstrated initial clearance of P.vivax parasitemia, c) Participant had no positive asexual P.vivax parasite count at any assessment prior to or on study Day 180 following initial parasite clearance, d) Participants did not take a concomitant medication with anti-malarial activity (excluding study treatment) at any point between Study Day 1 and their last parasite assessment, e) Participant was parasite-free at 6 months. The percentage of participants who were relapse-free at 6 months post dose has been presented.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Primaquine With DHA-PQP and DHA-PQP Alone	12 Percentage of participants	52 Percentage of participants	—

SECONDARY outcome

Timeframe: 4 months post-dose

Population: mITT Population.

A participant was considered to have demonstrated recurrence-free efficacy at 4 months if: a) Participant had non-zero P. vivax asexual parasite count at Baseline, b) Participant demonstrated initial clearance of P.vivax parasitemia, c) Participant had no positive asexual P.vivax parasite count at any assessment prior to or on Study Day 135 following initial parasite clearance, d) Participants did not take a concomitant medication with anti-malarial activity (excluding study treatment) at any point between Study Day 1 and their first parasite assessment after Study Day 105 (up to and including Study Day 135), e) Participant was parasite-free at 4 months. The rate of relapse-free efficacy was estimated by Kaplan-Meier methodology. The percentage of participants who were relapse-free at 4 months post dose has been presented.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Percentage of Participants With Relapse-free Efficacy at Four Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone	16 Percentage of participants	28 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to Day 180

Population: mITT Population.

Relapse is defined by a positive blood smear with or without vivax symptoms. Relapse is described as any recurrence of P. vivax malaria after clearance of the initial infection. The time to relapse (number of days between the date of first positive count and date of Study Day 1) was analyzed by the Kaplan-Meier method. The median number of days to relapse along with 95 percent (%) confidence interval (CI) has been presented for each treatment group.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Time to Relapse of P. Vivax Malaria	81.5 Days Interval 74.0 to 88.0	96.0 Days Interval 88.0 to 117.0	NA Days Interval 90.0 to NA indicates median and 95% CI (upper limit) could not be derived, as \<50% of participants experienced the event within the treatment arm.

SECONDARY outcome

Timeframe: Up to Day 7

Population: mITT Population.

Time to fever clearance is defined as time from first dose of treatment to the time when body temperature falls to normal and remains normal for at least 48 hours up to the Day 7 visit. Fever clearance is considered to have been achieved once an initial temperature of greater than 37.4 degree Celsius is reduced to a value less than or equal to 37.4 degree Celsius, in the absence of value greater than 37.4 degree Celsius in the following 48 hours up to Day 7 visit. The time taken to achieve fever clearance was analyzed by Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Time to Fever Clearance	16.5 Hours Interval 14.1 to 17.3	15.8 Hours Interval 13.1 to 18.8	16.8 Hours Interval 14.6 to 17.8

SECONDARY outcome

Timeframe: Up to Day 8

Population: mITT Population.

Parasite clearance time is defined as time needed to clear asexual parasite from the blood that is, parasite numbers falling below the limit of detection in the thick blood smear and remaining undetectable after \>= 6 hours later. The time to achieve parasite clearance was analyzed by Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Time to Parasite Clearance	18.1 Hours Interval 18.0 to 18.7	18.1 Hours Interval 18.0 to 18.3	18.0 Hours Interval 18.0 to 18.1

SECONDARY outcome

Timeframe: Up to Day 14

Population: mITT Population

Recrudescence was defined as blood stage treatment failure. A participant was considered to have had a recrudescence if both of the following were true: 1) if participant had a positive P. vivax asexual parasite count at Baseline and demonstrated clearance (i.e. two negative asexual P. vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval); 2) Participant had a positive genetically homologous asexual P. vivax parasite count on or before Study Day 14, after their zero count in days 1 to 5.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Recrudescence	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: Safety Population consisted of all randomized participants who received at least one dose of blinded study treatment.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function, other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Double-blind Treatment Phase Any AEs	41 Participants	41 Participants	34 Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Double-blind Treatment Phase Any SAEs	1 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Day 120

Population: Safety Population.

Blood samples were collected at indicated time points to analyze following chemistry parameters: alanine aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin, Creatine Kinase, Creatinine, Indirect Bilirubin and Urea. Clinical concern range for the parameters included ALT and AST (high: \>3 times Upper Limit of Normal \[ULN\]), ALP (high: \>2.5 times ULN), bilirubin and indirect bilirubin (high: \>1.5 times ULN), creatine kinase (high: \>5 times ULN), creatinine (high: \>3 times ULN) and urea (high: \>11.067 millimoles per Liter \[mmol/L\]. Data for any time on treatment has been presented.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Chemistry Values Outside Clinical Concern Range Urea, High	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Values Outside Clinical Concern Range ALT, High	1 Participants	3 Participants	0 Participants
Number of Participants With Chemistry Values Outside Clinical Concern Range ALP, High	1 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Values Outside Clinical Concern Range AST, High	0 Participants	1 Participants	0 Participants
Number of Participants With Chemistry Values Outside Clinical Concern Range Bilirubin, High	4 Participants	6 Participants	4 Participants
Number of Participants With Chemistry Values Outside Clinical Concern Range Creatine Kinase, High	7 Participants	6 Participants	6 Participants
Number of Participants With Chemistry Values Outside Clinical Concern Range Creatinine, High	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Values Outside Clinical Concern Range Indirect bilirubin, High	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Day 120

Population: Safety Population

Blood samples were collected to analyze the following hematology parameters: Hemoglobin, lymphocytes and Platelet count. The clinical concern ranges for the parameters included: hemoglobin (low: \<7 grams per deciliter), lymphocytes: (low: \<0.5x10\^9 cells per liter and high: \>4x10\^9 cells per liter),and platelets (low: \<50x10\^9 cells per liter). Data for any time on treatment has been presented.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Hematology Values Outside Clinical Concern Range Hemoglobin, Low	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Values Outside Clinical Concern Range Lymphocytes, High	3 Participants	4 Participants	2 Participants
Number of Participants With Hematology Values Outside Clinical Concern Range Lymphocytes, Low	0 Participants	0 Participants	1 Participants
Number of Participants With Hematology Values Outside Clinical Concern Range Platelets, Low	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: Safety Population.

12-lead ECG was obtained at indicated time points using an automated ECG machine that measured QTcF. Clinical concern range included:absolute QTcF interval (upper: \>480 milliseconds) and increase from Baseline in QTcF (upper: \>=60 milliseconds). Data for maximum post-Baseline increase \>=60 and \>480 milliseconds has been presented.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Electrocardiogram (ECG) Values Outside Clinical Concern Range-QT Interval Corrected Using Fredericia's Formula (QTcF)	2 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 3: 4 hours post DHA-PQP dose, Days 7 and 28

Population: Safety Population.

12-lead ECG was obtained at indicated time points using an automated ECG machine that measured QTcF interval. Change from Baseline is calculated as Post-Dose Visit Value minus Baseline value. Day 1 was considered as Baseline.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Change From Baseline in QT Interval Corrected by Fridericia's Formula (QTcF) Day 3: 4 hours post DHA-PQP dose	35.3 Milliseconds Standard Deviation 24.81	44.5 Milliseconds Standard Deviation 22.96	40.8 Milliseconds Standard Deviation 17.22
Change From Baseline in QT Interval Corrected by Fridericia's Formula (QTcF) Day 7	11.5 Milliseconds Standard Deviation 14.95	12.2 Milliseconds Standard Deviation 13.97	16.5 Milliseconds Standard Deviation 16.67
Change From Baseline in QT Interval Corrected by Fridericia's Formula (QTcF) Day 28	2.4 Milliseconds Standard Deviation 15.00	7.5 Milliseconds Standard Deviation 13.70	10.2 Milliseconds Standard Deviation 14.41

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Day 180

Population: Safety Population.

Body temperature was measured with participants in semi-supine position after 5 minutes of rest. Data was categorized as: body temperature 'low: \<36.5 degrees celsius', 'high: \>37.3 degrees celsius' and 'To Normal or No change'. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose vital sign value category was unchanged (e.g.,High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Day 1 was considered as Baseline.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Worst Case Body Temperature Results Relative to Normal Range Post-Baseline Relative to Baseline To Low	42 Participants	38 Participants	42 Participants
Number of Participants With Worst Case Body Temperature Results Relative to Normal Range Post-Baseline Relative to Baseline To Normal or No change	3 Participants	7 Participants	5 Participants
Number of Participants With Worst Case Body Temperature Results Relative to Normal Range Post-Baseline Relative to Baseline To High	10 Participants	14 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Day 180

Population: Safety Population.

SBP and DBP were measured with participants in semi-supine position after 5 minutes of rest. Data was categorized as: systolic blood pressure (SBP) (low: \<90 and high: \>120 millimeters of mercury \[mmHg\]); diastolic blood pressure (DBP) (low: \<60 and high: \>80 mmHg); and 'To Normal or No change'. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose vital sign value category was unchanged (e.g.,High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Day 1 was considered as Baseline.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results Relative to Normal Range Post-Baseline Relative to Baseline SBP, To Low	0 Participants	1 Participants	0 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results Relative to Normal Range Post-Baseline Relative to Baseline SBP, To Normal or No change	19 Participants	21 Participants	25 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results Relative to Normal Range Post-Baseline Relative to Baseline SBP, To High	31 Participants	29 Participants	25 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results Relative to Normal Range Post-Baseline Relative to Baseline DBP, To Low	11 Participants	9 Participants	15 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results Relative to Normal Range Post-Baseline Relative to Baseline DBP, To Normal or No change	16 Participants	20 Participants	16 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results Relative to Normal Range Post-Baseline Relative to Baseline DBP, To High	28 Participants	25 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Day 180

Population: Safety Population.

Pulse rate was measured with participants in semi-supine position after 5 minutes of rest. Data was categorized as: pulse rate low: \<60 beats per minute \[bpm\], high: \>100 bpm and 'To normal or No change'. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose vital sign value category was unchanged (e.g.,High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Day 1 was considered as Baseline.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Worst Case Pulse Rate Results Relative to Normal Range Post-Baseline Relative to Baseline To Low	19 Participants	26 Participants	23 Participants
Number of Participants With Worst Case Pulse Rate Results Relative to Normal Range Post-Baseline Relative to Baseline To Normal or No change	25 Participants	23 Participants	26 Participants
Number of Participants With Worst Case Pulse Rate Results Relative to Normal Range Post-Baseline Relative to Baseline To High	7 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Day 180

Population: Safety Population.

Respiratory rate was measured with participants in semi-supine position after 5 minutes of rest. Data was categorized as: respiratory rate low: \<12 breaths per minute', high: \>18 breaths per minute and 'To normal or No change'. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose vital sign value category was unchanged (e.g.,High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.Day 1 was considered as Baseline. Day 1 was considered as Baseline.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Worst Case Respiratory Rate Results Relative to Normal Range Post-Baseline Relative to Baseline To Low	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Respiratory Rate Results Relative to Normal Range Post-Baseline Relative to Baseline To Normal or No change	41 Participants	41 Participants	40 Participants
Number of Participants With Worst Case Respiratory Rate Results Relative to Normal Range Post-Baseline Relative to Baseline To High	9 Participants	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: Safety Population.

The number of participants with gastrointestinal AEs: nausea, vomiting, diarrhea, dyspepsia, abdominal distension, abdominal discomfort and constipation has been presented.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Gastrointestinal AEs Abdominal discomfort	0 Participants	0 Participants	2 Participants
Number of Participants With Gastrointestinal AEs Nausea	5 Participants	4 Participants	3 Participants
Number of Participants With Gastrointestinal AEs Vomiting	6 Participants	5 Participants	1 Participants
Number of Participants With Gastrointestinal AEs Diarrhea	5 Participants	2 Participants	2 Participants
Number of Participants With Gastrointestinal AEs Dyspepsia	2 Participants	3 Participants	4 Participants
Number of Participants With Gastrointestinal AEs Abdominal distension	1 Participants	1 Participants	1 Participants
Number of Participants With Gastrointestinal AEs Constipation	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Days 2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,18,20,21,22,24,26,28 and 60

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected for the assessment of methemoglobin/Total Hemoglobin (Hb). Methemoglobin is a type of Hb in the form of metalloprotein that cannot bind with oxygen, measured as percentage of methemoglobin in total hemoglobin. Change from Baseline is calculated as Post-Dose Visit Value minus Baseline value. Day 1 was considered as Baseline.

Outcome measures

SECONDARY outcome

Timeframe: Days 3, 5, 7, and 14

Population: Safety Population.

Blood samples were collected at indicated time points to analyze the hemoglobin level. Hemoglobin drop is defined as any one of the following occurring in the first 15 days of the study: a relative hemoglobin decrease of \>=30% from Baseline, or an absolute hemoglobin decrease of \>3 grams per liter from Baseline, or a drop in absolute hemoglobin to \<7.0 grams per decilter (g/dL). Number of participants with a protocol-defined hemoglobin SAEs has been presented.

Outcome measures

Outcome measures
Measure	DHA-PQP Only n=50 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Number of Participants With Protocol-defined SAE (Hemoglobin Drop) Day 3	0 Participants	0 Participants	0 Participants
Number of Participants With Protocol-defined SAE (Hemoglobin Drop) Day 5	0 Participants	0 Participants	0 Participants
Number of Participants With Protocol-defined SAE (Hemoglobin Drop) Day 7	0 Participants	0 Participants	0 Participants
Number of Participants With Protocol-defined SAE (Hemoglobin Drop) Day 14	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 60

Blood samples were collected at the indicated time points for the determination of oral clearance following tefenoquine co-administered with DHA-PQP and was to be calculated by covariate analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 60

Blood samples were collected at the indicated time points for the determination of volume of distribution following tefenoquine co-administered with DHA-PQP and was to be calculated by covariate analysis.

Outcome measures

Outcome data not reported

Adverse Events

DHA-PQP Only

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Tafenoquine+ DHA-PQP

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Primaquine+DHA-PQP

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

DHA-PQP Only (Open-label Primaquine Phase)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tafenoquine 300 mg+DHA-PQP (Open-label Primaquine Phase)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Primaquine 15 mg+DHA-PQP (Open-label Primaquine Phase)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DHA-PQP Only n=50 participants at risk Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	DHA-PQP Only (Open-label Primaquine Phase) n=6 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received oral doses of primaquine matched placebo once daily for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine 300 mg+DHA-PQP (Open-label Primaquine Phase) n=12 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received oral doses of primaquine matched placebo once daily for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine 15 mg+DHA-PQP (Open-label Primaquine Phase) n=26 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received oral doses of primaquine 15 mg once daily for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Hepatobiliary disorders Cholelithiasis	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	2.0% 1/50 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	2.0% 1/50 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	2.0% 1/50 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Investigations Electrocardiogram QT prolonged	2.0% 1/50 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Vascular disorders Hypertensive urgency	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	2.0% 1/50 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Renal and urinary disorders Ureterolithiasis	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	8.3% 1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.

Other adverse events

Other adverse events
Measure	DHA-PQP Only n=50 participants at risk Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	DHA-PQP Only (Open-label Primaquine Phase) n=6 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received oral doses of primaquine matched placebo once daily for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine 300 mg+DHA-PQP (Open-label Primaquine Phase) n=12 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received oral doses of primaquine matched placebo once daily for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine 15 mg+DHA-PQP (Open-label Primaquine Phase) n=26 participants at risk Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received oral doses of primaquine 15 mg once daily for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Gastrointestinal disorders Dyspepsia	4.0% 2/50 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	6.0% 3/50 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	8.0% 4/50 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Musculoskeletal and connective tissue disorders Myalgia	4.0% 2/50 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	12.0% 6/50 • Number of events 9 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	14.0% 7/50 • Number of events 7 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Infections and infestations Upper respiratory tract infection	14.0% 7/50 • Number of events 7 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	22.0% 11/50 • Number of events 13 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	16.0% 8/50 • Number of events 8 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Infections and infestations Nasopharyngitis	14.0% 7/50 • Number of events 8 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	10.0% 5/50 • Number of events 6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	4.0% 2/50 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Infections and infestations Rhinitis	6.0% 3/50 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	8.0% 4/50 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	4.0% 2/50 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Infections and infestations Pharyngitis	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	10.0% 5/50 • Number of events 5 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	4.0% 2/50 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Gastrointestinal disorders Nausea	10.0% 5/50 • Number of events 5 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	8.0% 4/50 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	6.0% 3/50 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Gastrointestinal disorders Vomiting	12.0% 6/50 • Number of events 7 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	10.0% 5/50 • Number of events 6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	2.0% 1/50 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Gastrointestinal disorders Diarrhoea	10.0% 5/50 • Number of events 5 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	4.0% 2/50 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	4.0% 2/50 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Nervous system disorders Headache	6.0% 3/50 • Number of events 6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	8.0% 4/50 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	16.0% 8/50 • Number of events 9 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
General disorders Malaise	2.0% 1/50 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	4.0% 2/50 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	6.0% 3/50 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
General disorders Asthenia	6.0% 3/50 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	2.0% 1/50 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	2.0% 1/50 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
General disorders Chills	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	6.0% 3/50 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
Investigations Electrocardiogram QT prolonged	6.0% 3/50 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	12.0% 6/50 • Number of events 6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	4.0% 2/50 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.
General disorders Pyrexia	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/50 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	8.3% 1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.	0.00% 0/26 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 180 for double-blind treatment phase and from Day 180 to Day 195 for open-label treatment phase AEs and SAEs were collected in the Safety Population for a) Open Label DHA-PQP phase, b) Double-blind treatment phase and c) Open-label phase comprised of participants who did not relapse during the double-blind phase and went onto the open-label primaquine phase.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	DHA-PQP Only n=48 Participants Participants received either 3 tablets (body weight: \<75 kilograms \[kg\]) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo tablet administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or Day 2. Participants who did not relapse before Day 180 were administered 0.5 milligrams (mg)/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Tafenoquine+ DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine 300 mg administered as a single oral dose and once daily oral doses of primaquine matched placebo for 14 days. Blinded treatment started on Day 1 or 2. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.	Primaquine+DHA-PQP n=50 Participants Participants received either 3 tablets (body weight: \<75 kg) or 4 tablets (body weight: \>=75 kg) per day of open-label DHA-PQP on Days 1 to 3. Participants also received blinded treatment with tafenoquine matched placebo administered as a single oral dose and once daily oral doses of primaquine 15 mg for 14 days. Participants who did not relapse before Day 180 were administered 0.5 mg/kg open-label primaquine once daily for 14 days after completion of the double-blind phase.
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 2, n=48, 50, 50	-0.13 Percentage of Methemoglobin in total Hb Standard Deviation 0.234	-0.07 Percentage of Methemoglobin in total Hb Standard Deviation 0.341	-0.06 Percentage of Methemoglobin in total Hb Standard Deviation 0.260
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 3, n=48, 50, 50	-0.16 Percentage of Methemoglobin in total Hb Standard Deviation 0.211	-0.04 Percentage of Methemoglobin in total Hb Standard Deviation 0.323	0.01 Percentage of Methemoglobin in total Hb Standard Deviation 0.270
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 4, n=48, 50, 50	-0.16 Percentage of Methemoglobin in total Hb Standard Deviation 0.228	0.06 Percentage of Methemoglobin in total Hb Standard Deviation 0.367	0.28 Percentage of Methemoglobin in total Hb Standard Deviation 0.438
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 5, n=48, 50, 50	-0.18 Percentage of Methemoglobin in total Hb Standard Deviation 0.244	0.12 Percentage of Methemoglobin in total Hb Standard Deviation 0.382	0.62 Percentage of Methemoglobin in total Hb Standard Deviation 0.714
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 6, n=46, 49, 50	-0.15 Percentage of Methemoglobin in total Hb Standard Deviation 0.204	0.16 Percentage of Methemoglobin in total Hb Standard Deviation 0.437	0.91 Percentage of Methemoglobin in total Hb Standard Deviation 0.869
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 7, n=48, 50, 50	-0.19 Percentage of Methemoglobin in total Hb Standard Deviation 0.248	0.19 Percentage of Methemoglobin in total Hb Standard Deviation 0.454	1.20 Percentage of Methemoglobin in total Hb Standard Deviation 1.213
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 8, n=46, 48, 48	-0.12 Percentage of Methemoglobin in total Hb Standard Deviation 0.224	0.23 Percentage of Methemoglobin in total Hb Standard Deviation 0.487	1.41 Percentage of Methemoglobin in total Hb Standard Deviation 1.329
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 9, n=46, 47, 47	-0.13 Percentage of Methemoglobin in total Hb Standard Deviation 0.245	0.24 Percentage of Methemoglobin in total Hb Standard Deviation 0.426	1.53 Percentage of Methemoglobin in total Hb Standard Deviation 1.325
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 10, n=47, 45, 49	-0.16 Percentage of Methemoglobin in total Hb Standard Deviation 0.279	0.24 Percentage of Methemoglobin in total Hb Standard Deviation 0.456	1.69 Percentage of Methemoglobin in total Hb Standard Deviation 1.314
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 11, n=47, 44, 49	-0.13 Percentage of Methemoglobin in total Hb Standard Deviation 0.232	0.18 Percentage of Methemoglobin in total Hb Standard Deviation 0.445	1.82 Percentage of Methemoglobin in total Hb Standard Deviation 1.324
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 12, n=47, 47, 50	-0.13 Percentage of Methemoglobin in total Hb Standard Deviation 0.256	0.18 Percentage of Methemoglobin in total Hb Standard Deviation 0.404	1.92 Percentage of Methemoglobin in total Hb Standard Deviation 1.436
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 13, n=48, 48, 48	-0.14 Percentage of Methemoglobin in total Hb Standard Deviation 0.256	0.18 Percentage of Methemoglobin in total Hb Standard Deviation 0.419	2.02 Percentage of Methemoglobin in total Hb Standard Deviation 1.409
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 14, n=48, 50, 50	-0.18 Percentage of Methemoglobin in total Hb Standard Deviation 0.243	0.12 Percentage of Methemoglobin in total Hb Standard Deviation 0.404	2.01 Percentage of Methemoglobin in total Hb Standard Deviation 1.436
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 15, n=17, 22, 14	-0.08 Percentage of Methemoglobin in total Hb Standard Deviation 0.213	0.00 Percentage of Methemoglobin in total Hb Standard Deviation 0.363	2.13 Percentage of Methemoglobin in total Hb Standard Deviation 1.019
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 16, n=43, 48, 47	-0.12 Percentage of Methemoglobin in total Hb Standard Deviation 0.216	0.12 Percentage of Methemoglobin in total Hb Standard Deviation 0.369	1.84 Percentage of Methemoglobin in total Hb Standard Deviation 1.259
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 18, n=46, 48, 49	-0.12 Percentage of Methemoglobin in total Hb Standard Deviation 0.246	0.11 Percentage of Methemoglobin in total Hb Standard Deviation 0.357	1.29 Percentage of Methemoglobin in total Hb Standard Deviation 0.982
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 20, n=42, 49, 48	-0.09 Percentage of Methemoglobin in total Hb Standard Deviation 0.260	0.06 Percentage of Methemoglobin in total Hb Standard Deviation 0.362	0.80 Percentage of Methemoglobin in total Hb Standard Deviation 0.744
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 21, n=43, 48, 48	-0.07 Percentage of Methemoglobin in total Hb Standard Deviation 0.382	0.03 Percentage of Methemoglobin in total Hb Standard Deviation 0.262	0.69 Percentage of Methemoglobin in total Hb Standard Deviation 0.680
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 22, n=45, 49, 48	-0.13 Percentage of Methemoglobin in total Hb Standard Deviation 0.294	0.01 Percentage of Methemoglobin in total Hb Standard Deviation 0.293	0.49 Percentage of Methemoglobin in total Hb Standard Deviation 0.565
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 24, n=41, 46, 47	-0.11 Percentage of Methemoglobin in total Hb Standard Deviation 0.258	0.03 Percentage of Methemoglobin in total Hb Standard Deviation 0.329	0.41 Percentage of Methemoglobin in total Hb Standard Deviation 0.424
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 26, n=44, 45, 47	-0.17 Percentage of Methemoglobin in total Hb Standard Deviation 0.256	0.03 Percentage of Methemoglobin in total Hb Standard Deviation 0.279	0.19 Percentage of Methemoglobin in total Hb Standard Deviation 0.347
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 28, n=47, 50, 50	-0.15 Percentage of Methemoglobin in total Hb Standard Deviation 0.248	0.01 Percentage of Methemoglobin in total Hb Standard Deviation 0.284	0.08 Percentage of Methemoglobin in total Hb Standard Deviation 0.314
Change From Baseline in Methemoglobin/ Total Hemoglobin Day 60, n=47, 50, 49	-0.11 Percentage of Methemoglobin in total Hb Standard Deviation 0.260	-0.07 Percentage of Methemoglobin in total Hb Standard Deviation 0.326	-0.01 Percentage of Methemoglobin in total Hb Standard Deviation 0.245