Trial Outcomes & Findings for Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC) (NCT NCT02573493)

Last Updated: 2024-12-27

Results Overview

* Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note. * Complete response = complete resolution - 100% decrease/minimal residual mucosal abnormality

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

Completion of 2 cycles (approximately 6 weeks)

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplain will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Not Enrolled in Any Arm -Determined to be not eligible after enrollment to study and was therefore not enrolled on any study arm.
Overall Study STARTED	40	40	15	1
Overall Study COMPLETED	40	40	15	0
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplain will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Not Enrolled in Any Arm -Determined to be not eligible after enrollment to study and was therefore not enrolled on any study arm.
Overall Study Determined to not be eligible after enrollment	0	0	0	1

Baseline Characteristics

Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Not Enrolled in Any Arm n=1 Participants -Determined to be not eligible after enrollment to study and was therefore not enrolled on any study arm.	Total n=96 Participants Total of all reporting groups
Age, Continuous	57.5 years n=5 Participants	65.5 years n=7 Participants	61 years n=5 Participants	62 years n=4 Participants	61 years n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	32 Participants n=7 Participants	14 Participants n=5 Participants	0 Participants n=4 Participants	82 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	39 Participants n=7 Participants	15 Participants n=5 Participants	1 Participants n=4 Participants	95 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	37 Participants n=7 Participants	15 Participants n=5 Participants	1 Participants n=4 Participants	85 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	15 participants n=5 Participants	1 participants n=4 Participants	96 participants n=21 Participants

PRIMARY outcome

Timeframe: Completion of 2 cycles (approximately 6 weeks)

Population: Only participants enrolled in Arm 1 and Arm 2 are evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site	28 Participants	8 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Completion of treatment (estimated to be 11-15 weeks)

Population: Only participants enrolled in Arm 3 are evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arm 3: Median Percent Weight Loss	—	—	6.7 percentage of weight loss Interval 2.2 to 12.9	—	—	—

SECONDARY outcome

Timeframe: Completion of 2 cycles (approximately 6 weeks)

* Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ENT physician's clinical exam note. * Partial response - 99-50% decrease

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site	11 Participants	28 Participants	6 Participants	—	—	—

SECONDARY outcome

Timeframe: Completion of 2 cycles (approximately 6 weeks)

* The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note. * Complete response - complete resolution - 100% decrease/minimal residual mucosal abnormality

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=30 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=33 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=11 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes	18 Participants	14 Participants	3 Participants	—	—	—

SECONDARY outcome

Timeframe: Completion of 2 cycles (approximately 6 weeks)

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=30 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=33 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=11 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes	11 Participants	14 Participants	7 Participants	—	—	—

SECONDARY outcome

Timeframe: Completion of 2 cycles (approximately 6 weeks)

-Computed tomography (CT) scan (intravenous contrast preferred) to document and measure the extent of the primary tumor size and involved regional neck nodes. RECIST 1.1 will be used to determine response at the primary tumor site, at the involved regional neck nodes and the radiographic overall tumor response.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=39 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria Complete response	2 Participants	1 Participants	1 Participants	—	—	—
Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria Partial response	22 Participants	20 Participants	13 Participants	—	—	—

SECONDARY outcome

Timeframe: Completion of 2 cycles (approximately 6 weeks)

Population: The data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days after completion of treatment (estimated to be 15-25 weeks)

Compare to those observed with APF with the objective that Arm 1 will be at least 25% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 30%) and Arm 2 will be at least 50% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 20%).

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy n=39 Participants * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy n=35 Participants * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy n=15 Participants * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	23 Participants	17 Participants	4 Participants	37 Participants	35 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and one year after completion of treatment (approximately 74 weeks)

-The FACT/GOG-NTX-4 questionnaire has 4 questions about neuropathy (numbness/tingling in hands/feet and discomfort in hands/feet) with answers ranging from 0 (Not at all) to 4 (Very Much). The total score ranges from 0 to 16. A lower score indicates less neuropathy symptoms.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=39 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4 Baseline	0.19 score on a scale Interval 0.02 to 0.36	0.38 score on a scale Interval 0.18 to 0.59	0.27 score on a scale Interval 0.04 to 0.57	—	—	—
Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4 End of treatment	1.55 score on a scale Interval 1.09 to 2.01	0.91 score on a scale Interval 0.4 to 1.33	1.54 score on a scale Interval 0.9 to 2.18	—	—	—

SECONDARY outcome

Timeframe: Baseline and one year after completion of treatment (approximately 74 weeks)

-The FACT-H\&N has 5 domains with 39 items including physical well-being (PWB), social/family well being (SWB), emotional well-being (EWB), functional well-being (FWB), and head \& neck cancer (HNCS) with answers ranging from 0 (Not at all) to 4 (Very Much). The PWB subscale score ranges from 0-28. The SWB subscale score ranges from 0-28. The EWB subscale score ranges from 0-24. The FWB subscale score ranges from 0-28. The HNCS subscale score ranges from 0-40. To obtain the total score all subscales are added together. The total score ranges from 0-148 with a higher score indicating a better quality of life.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=39 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N Baseline	2.02 score on a scale Interval 1.93 to 2.11	1.86 score on a scale Interval 1.74 to 1.97	2.07 score on a scale Interval 1.94 to 2.2	—	—	—
Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N End of treatment	1.98 score on a scale Interval 1.89 to 2.06	1.82 score on a scale Interval 1.71 to 1.93	2.00 score on a scale Interval 1.86 to 2.15	—	—	—

SECONDARY outcome

Timeframe: Through one year after completion of treatment (approximately 74 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

OS: duration of time from date of diagnosis to late date alive or time of death from any cause.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=13 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)	100 percentage of particpants	87.50 percentage of particpants	92.31 percentage of particpants	—	—	—

SECONDARY outcome

Timeframe: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

OS: duration of time from date of diagnosis to last date alive or time of death from any cause.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=13 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)	97.44 percentage of participants	69.63 percentage of participants	84.62 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Through one year after completion of treatment (approximately 74 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

DFS: duration of time from last date of treatment to time of disease progression or death from any cause.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=13 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)	87.50 percentage of participants	62.50 percentage of participants	76.92 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

DFS: duration of time from last date of treatment to time of disease progression or death from any cause.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=13 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)	87.50 percentage of participants	51.81 percentage of participants	69.23 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Through one year after completion of treatment (approximately 74 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

◦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=13 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)	92.50 percentage of participants	67.50 percentage of participants	76.92 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

◦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=13 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)	87.43 percentage of participants	54.89 percentage of participants	69.23 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Completion of 2 cycles (approximately 6 weeks)

Population: Only participants enrolled in Arm 3 are evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arm 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site	—	—	9 Participants	—	—	—

SECONDARY outcome

Timeframe: Completion of 2 cycles (approximately 6 weeks)

Population: Data was not collected for this outcome measure.

-Stratified for HPV status

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days after completion of treatment (estimated to be 15-25 weeks)

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=15 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=39 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy n=15 Participants * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arm 1 and Arm 3: Comparison of the Rate of Grade 3/4 Adverse Events	23 Participants	4 Participants	37 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=39 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=35 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Comparison of Median Absolute Weight Loss in Arms 2 and 3 to Arm 1	8.4 kilograms Interval 3.1 to 20.8	5.2 kilograms Interval 4.9 to 14.6	7.0 kilograms Interval 1.7 to 12.8	—	—	—

SECONDARY outcome

Timeframe: From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=15 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Comparison of Median Percent Weight Loss in Arms 2 and 3 to Arm 1	9.1 median percent of weight loss Interval 6.7 to 11.2	6.6 median percent of weight loss Interval 2.6 to 8.1	6.7 median percent of weight loss Interval 2.2 to 9.9	—	—	—

SECONDARY outcome

Timeframe: Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

OS: duration of time from start of treatment to time of death from any cause

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=13 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)	77.1 percentage of participants	40.5 percentage of participants	68.4 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

◦PFS: duration of time from start of treatment to time of progression or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=13 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)	77.2 percentage of participants	33.8 percentage of participants	69.2 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT n=13 Participants * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)	77.2 percentage of participants	32.0 percentage of participants	69.2 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=13 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arm 1 and Arm 3: Kaplan-Meier Estimate of Overall Survival	77.1 percentage of participants	68.4 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=13 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arm 1 and Arm 3: Kaplan-Meier Estimate of Disease-free Survival	77.2 percentage of participants	69.2 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)

Population: 2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.

Outcome measures

Outcome measures
Measure	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT n=40 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin (if cannot receive cisplatin will receive cetuximab) which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 2: Nab-Paclitaxel (A) + CRT n=13 Participants * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1 CRT: Cisplatin + Radiation Therapy * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Arm 1 and Arm 3: Kaplan-Meier Estimate of Progression-free Survival	77.2 percentage of participants	69.2 percentage of participants	—	—	—	—

Adverse Events

Arm 1 & 2 ERT: Cetuximab + Radiation Therapy

Serious events: 6 serious events

Other events: 42 other events

Deaths: 0 deaths

Arm 3 CR: Cisplatin + Radiation Therapy

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Arm 2: Nab-Paclitaxel + ERT Follow-up

Serious events: 1 serious events

Other events: 0 other events

Deaths: 21 deaths

Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up

Serious events: 1 serious events

Other events: 0 other events

Deaths: 4 deaths

Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction

Serious events: 6 serious events

Other events: 40 other events

Deaths: 0 deaths

Arm 2: Nab-Paclitaxel (A) Induction

Serious events: 6 serious events

Other events: 40 other events

Deaths: 0 deaths

Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm 1 CRT: Cisplatin + Radiation Therapy

Serious events: 9 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy n=42 participants at risk * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy n=15 participants at risk * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up n=40 participants at risk -Follow-up time period of up to 72 months post-completion of therapy	Arm 2: Nab-Paclitaxel + ERT Follow-up n=40 participants at risk -Follow-up time period of up to 72 months post-completion of therapy	Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up n=15 participants at risk -Follow-up time period of up to 72 months post-completion of therapy	Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction n=40 participants at risk * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates.	Arm 2: Nab-Paclitaxel (A) Induction n=40 participants at risk * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction n=15 participants at risk * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT	Arm 1 CRT: Cisplatin + Radiation Therapy n=34 participants at risk * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
Gastrointestinal disorders Nausea	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Catheter related infection	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Vomiting	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Vascular disorders Thrombosis/embolism	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Dysphagia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Creatinine	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypokalemia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Dehydration	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Febrile neutropenia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Syncope	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Diarrhea	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Sepsis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Renal failure	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Fever	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Agitation	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Blood infection	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Death NOS	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Cardiac/heart pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Confusion	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Mucositis oral	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Fatigue	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Vascular disorders Hypertension	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Bladder obstruction	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Urinary tract infection	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hyperglycemia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Cellulitis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypercalcemia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Throat/pharynx/larynx pain	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Immune system disorders Allergic reaction - cetuximab	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Chest/thorax pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Anxiety	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Malabsorption	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Injury, poisoning and procedural complications Fracture	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Rectal hemorrhage	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death due to disease progression NOS	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Anorexia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.

Other adverse events

Other adverse events
Measure	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy n=42 participants at risk * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.	Arm 3 CR: Cisplatin + Radiation Therapy n=15 participants at risk * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.	Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up n=40 participants at risk -Follow-up time period of up to 72 months post-completion of therapy	Arm 2: Nab-Paclitaxel + ERT Follow-up n=40 participants at risk -Follow-up time period of up to 72 months post-completion of therapy	Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up n=15 participants at risk -Follow-up time period of up to 72 months post-completion of therapy	Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction n=40 participants at risk * Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates.	Arm 2: Nab-Paclitaxel (A) Induction n=40 participants at risk * Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates.	Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction n=15 participants at risk * 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT	Arm 1 CRT: Cisplatin + Radiation Therapy n=34 participants at risk * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
Gastrointestinal disorders Diarrhea	21.4% 9/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	30.0% 12/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.5% 7/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	53.3% 8/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.6% 7/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Weight loss	64.3% 27/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	53.3% 8/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 8/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	22.5% 9/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	85.3% 29/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Atrial fibrillation	9.5% 4/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Cardiac ischemia/infarction	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Carotid artery stenosis	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Congestive heart failure	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Coronary artery disease	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	15.0% 6/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Mitral valve prolapse	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Sick sinus syndrome	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Sinus bradycardia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Sinus tachycardia	26.2% 11/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	27.5% 11/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	23.5% 8/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Cardiac disorders Systolic murmur	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Ear and labyrinth disorders Ear pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 8/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Ear and labyrinth disorders Hearing (with baseline audiogram)	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Ear and labyrinth disorders Hearing (without monitoring program)	31.0% 13/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.0% 14/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	11.8% 4/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Ear and labyrinth disorders Middle ear pain	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Ear and labyrinth disorders Tinnitus	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	27.5% 11/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	41.2% 14/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Endocrine disorders Hyperthyroidism	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Eye disorders Corneal abrasion	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Eye disorders Eye pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Eye disorders Eyelid dysfunction	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Eye disorders Eyelid swelling	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Eye disorders Glaucoma	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Eye disorders Subconjuctival sclera hemorrhage	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Eye disorders Vision photophobia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Eye disorders Watery eyes	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Abdominal pain	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Colitis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Colon polyps	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Constipation	38.1% 16/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.0% 14/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.0% 14/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	53.3% 8/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.3% 12/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Dental/teeth/periodontal pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Distension/bloating	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Dry mouth	52.4% 22/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	100.0% 15/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	58.8% 20/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Dysgeusia	40.5% 17/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	86.7% 13/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.5% 7/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	60.0% 9/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	50.0% 17/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Dyspepsia/heartburn	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 3/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Dysphagia	69.0% 29/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	86.7% 13/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	50.0% 20/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	62.5% 25/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	58.8% 20/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders GERD	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	15.0% 6/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.6% 7/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Ileus	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Malabsorption	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Mucositis oral	81.0% 34/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	100.0% 15/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	76.5% 26/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Nausea	38.1% 16/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	60.0% 9/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	45.0% 18/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.0% 14/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	80.0% 12/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	70.6% 24/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Odynophagia	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	11.8% 4/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Oral cavity hemorrhage	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Oral cavity pain	9.5% 4/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	23.5% 8/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Oropharyngeal erythema	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Rectal hemorrhage	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Salivary gland changes/saliva	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Stoma hemorrhage	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Stomach stricture	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Stomatitis (oral cavity)	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Teeth (dental caries)	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Gastrointestinal disorders Vomiting	16.7% 7/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	38.2% 13/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Cervical adenopathy	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Face pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Fatigue	61.9% 26/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	86.7% 13/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	60.0% 24/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	52.5% 21/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	66.7% 10/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	85.3% 29/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Fever	9.5% 4/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.6% 6/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Flu-like syndrome	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders General edema	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Head and neck edema	9.5% 4/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Limb edema	28.6% 12/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 8/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.6% 6/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Obesity	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Pain - NOS	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Pain in bottoms of feet	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
General disorders Rigors/chills	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	11.8% 4/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Immune system disorders Agammaglobulinemia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Immune system disorders Allergic reaction	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Immune system disorders Allergic reaction - cetuximab	11.9% 5/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Bacteremia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Blood infection	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Catheter related infection	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Cellulitis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Febrile neutropenia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Lung infection	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Oral thrush	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	11.8% 4/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Paronychia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Pneumonia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Shingles	16.7% 7/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Skin infection	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Tooth infection	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Upper airway NOS infection	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Urinary tract infection	9.5% 4/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Viral hepatitis	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Infections and infestations Viral respiratory infection	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Injury, poisoning and procedural complications Bruising	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Injury, poisoning and procedural complications Dermatitis - chemoradiation	78.6% 33/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	80.0% 12/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	61.8% 21/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Injury, poisoning and procedural complications Dermatitis - chemotherapy	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Injury, poisoning and procedural complications Fall	11.9% 5/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Injury, poisoning and procedural complications Fracture	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Injury, poisoning and procedural complications G-tube pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Injury, poisoning and procedural complications Induration	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations ALT	19.0% 8/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.5% 7/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 8/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.6% 6/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations AST	19.0% 8/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	22.5% 9/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Alkaline phosphatase	16.7% 7/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	15.0% 6/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	14.7% 5/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Cardiac troponin I	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Creatinine	26.2% 11/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	22.5% 9/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.0% 14/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	58.8% 20/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Hemoglobin	83.3% 35/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	100.0% 15/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	100.0% 40/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	87.5% 35/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	100.0% 15/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	100.0% 34/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Hyperbilirubinemia	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Hypercholesterolemia	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations INR	26.2% 11/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.6% 7/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Leukocytes	26.2% 11/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	53.3% 8/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	67.5% 27/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	62.5% 25/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	80.0% 12/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	88.2% 30/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Lymphopenia	83.3% 35/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	80.0% 12/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	60.0% 24/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	62.5% 25/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	53.3% 8/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	100.0% 34/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Neutropenia (ANC)	11.9% 5/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	67.5% 27/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	52.5% 21/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	86.7% 13/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	76.5% 26/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations PTT	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Investigations Platelets	16.7% 7/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 16/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	67.6% 23/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Acidosis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Anorexia	40.5% 17/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 8/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.5% 7/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 3/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	23.5% 8/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Dehydration	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.3% 12/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Diabetes	26.2% 11/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	22.5% 9/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	11.8% 4/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders GFR	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypercalcemia	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hyperglycemia	21.4% 9/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 8/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	22.5% 9/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.5% 9/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hyperkalemia	11.9% 5/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	25.0% 10/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.6% 7/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hyperlipidemia	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypernatremia	11.9% 5/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypertriglyceridemia	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypoalbuminemia	61.9% 26/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	22.5% 9/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	30.0% 12/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	58.8% 20/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypocalcemia	40.5% 17/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	25.0% 10/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	15.0% 6/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	47.1% 16/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypoglycemia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypokalemia	33.3% 14/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	47.1% 16/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypomagnesemia	26.2% 11/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 3/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	15.0% 6/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.5% 9/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hyponatremia	38.1% 16/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	27.5% 11/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.0% 14/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	70.6% 24/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Hypophosphatemia	16.7% 7/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.6% 7/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Armpit pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Arthritis	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Back pain	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Extremity muscle weakness	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Extremity/limb pain	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	11.8% 4/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Gout	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Jaw pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Joint pain	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Joint-function	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Knee pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Kyphosis	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Leg cramps	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Lower extremity muscle weakness	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Lower limb generalized muscle weakness	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Muscle pain	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Neck pain	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Osteonecrosis	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Shoulder pain	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Soft tissue necrosis - neck	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Musculoskeletal and connective tissue disorders Trismus	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.5% 7/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	15.0% 6/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.6% 6/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	11.9% 5/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 8/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Anoxic brain injury	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Apnea	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Ataxia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders CNS cerebrovascular ischemia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders CNS ischemia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Confusion	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Dementia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Dizziness	16.7% 7/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.5% 7/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 3/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.6% 6/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Dysphasia	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Headache	9.5% 4/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 3/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Memory impairment	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Parkinson's disease	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Seizure	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Nervous system disorders Syncope	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Agitation	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Anxiety	16.7% 7/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.5% 7/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	22.5% 9/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 3/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.5% 9/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Depression	11.9% 5/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.6% 6/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Insomnia	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders OCD	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Panic attack	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Psychosis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Psychosis (bipolar disorder)	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Psychiatric disorders Sensory neuropathy	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	60.0% 9/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	15.0% 6/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	27.5% 11/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	41.2% 14/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders BPH	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Chronic kidney disease	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Chronic renal insufficiency	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Dysuria	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Hematuria	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Kidney stone	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Lower urinary tract symptoms	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Polycistic kidney disease	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Proteinuria	16.7% 7/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.6% 7/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Renal failure	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Urinary frequency	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Urinary hemorrhage	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Renal and urinary disorders Urinary incontinence	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.5% 7/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.6% 7/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Aspiration	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Bronchospasm/wheezing	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders COPD	19.0% 8/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 8/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Chest/thorax NOS pain	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Chronic lung disease	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	23.8% 10/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.0% 14/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	12.5% 5/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	47.1% 16/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 6/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	25.0% 10/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	11.8% 4/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Hiccoughs	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Larynx hemorrhage	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Nose hemorrhage	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	8.8% 3/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Nose pain	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Pharynx hemorrhage	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders RSV	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Respiratory tract NOS hemorrhage	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Sarcoidosis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Sinus infection	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Throat/pharynx/larynx pain	33.3% 14/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	32.5% 13/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	30.0% 12/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	50.0% 17/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Trachea hemorrhage	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	54.8% 23/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 16/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	55.0% 22/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	41.2% 14/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Acne	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Alopecia	50.0% 21/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	37.5% 15/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	35.0% 14/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	26.7% 4/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	58.8% 20/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Boil	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Cystic lesion	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Dry skin	11.9% 5/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	11.8% 4/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Ecchymoses	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Hyperpigmentation	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.6% 7/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Hypopigmentation	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Nail changes	4.8% 2/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	13.3% 2/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.0% 2/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 3/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Rash unexplained	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Rash/desquamation	11.9% 5/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	17.5% 7/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	25.0% 10/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	20.0% 3/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	14.7% 5/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Rash: acneiform	42.9% 18/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Skin breakdown/decubitus ulcer	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Sweating	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Ulceration	7.1% 3/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Skin and subcutaneous tissue disorders Ungual infection	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Vascular disorders Hypertension	61.9% 26/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	40.0% 6/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	75.0% 30/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	75.0% 30/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	46.7% 7/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	73.5% 25/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Vascular disorders Hypotension	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	7.5% 3/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	5.9% 2/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Vascular disorders Peripheral vascular disease	2.4% 1/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Vascular disorders Thrombophlebitis	0.00% 0/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.9% 1/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
Vascular disorders Thrombosis/embolism	9.5% 4/42 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	6.7% 1/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	— 0/0 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	10.0% 4/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	2.5% 1/40 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	0.00% 0/15 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.	11.8% 4/34 • -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment). -Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.

Additional Information

Douglas R. Adkins, M.D.

Washington University School of Medicine

Phone: 314-747-8475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place