Trial Outcomes & Findings for Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women (NCT NCT03164564)

NCT ID: NCT03164564

Last Updated: 2025-10-09

Results Overview

The number of participants with an incident HIV infection that is confirmed by the HPTN Laboratory Center and Endpoint Adjudication Committee.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 3224 participants
• Primary outcome timeframe: HIV tests at enrollment, weeks 2, 4, and 5, then every 4 weeks through week 25, then every 8 weeks. Analyzed through week 185 or the date of DSMB decision to unblind all participants, whichever is earliest.
• Results posted on: 2025-10-09

Participant Flow

Participant milestones

Measure	Arm A: CAB + Placebo TDF/FTC + CAB LA During Step 1, participants will receive daily oral CAB and oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral CAB: CAB 30 mg tablet Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral TDF/FTC: Placebo tablets CAB LA: 600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle	Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA During Step 1, participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks. In Step 2, participants will receive daily TDF/FTC and placebo for CAB LA injections at two times points 4 weeks apart and every 8 weeks thereafter beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral CAB: Placebo tablets Placebo for CAB LA: Administered as one 3 mL intramuscular injection in the gluteal muscle
Overall Study STARTED	1614	1610
Overall Study Ongoing	1586	1586
Overall Study Terminated From the Study	25	17
Overall Study COMPLETED	3	7
Overall Study NOT COMPLETED	1611	1603

Reasons for withdrawal

Measure	Arm A: CAB + Placebo TDF/FTC + CAB LA During Step 1, participants will receive daily oral CAB and oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral CAB: CAB 30 mg tablet Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral TDF/FTC: Placebo tablets CAB LA: 600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle	Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA During Step 1, participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks. In Step 2, participants will receive daily TDF/FTC and placebo for CAB LA injections at two times points 4 weeks apart and every 8 weeks thereafter beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral CAB: Placebo tablets Placebo for CAB LA: Administered as one 3 mL intramuscular injection in the gluteal muscle
Overall Study Death	3	0
Overall Study Withdrawal by Subject	20	15
Overall Study Lost to Follow-up	2	0
Overall Study Physician Decision	0	1
Overall Study Adverse Event	0	1
Overall Study Ongoing	1586	1586

Baseline Characteristics

Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

Baseline characteristics by cohort

Measure	Arm A: CAB + Placebo TDF/FTC + CAB LA n=1614 Participants During Step 1, participants will receive daily oral CAB and oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral CAB: CAB 30 mg tablet Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral TDF/FTC: Placebo tablets CAB LA: 600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle	Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA n=1610 Participants During Step 1, participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks. In Step 2, participants will receive daily TDF/FTC and placebo for CAB LA injections at two times points 4 weeks apart and every 8 weeks thereafter beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral CAB: Placebo tablets Placebo for CAB LA: Administered as one 3 mL intramuscular injection in the gluteal muscle	Total n=3224 Participants Total of all reporting groups
Age, Continuous	25.0 years n=93 Participants	25.0 years n=4 Participants	25.0 years n=27 Participants
Age, Customized <25	800 Participants n=93 Participants	794 Participants n=4 Participants	1594 Participants n=27 Participants
Age, Customized >=25	814 Participants n=93 Participants	816 Participants n=4 Participants	1630 Participants n=27 Participants
Sex: Female, Male Female	1614 Participants n=93 Participants	1610 Participants n=4 Participants	3224 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1614 Participants n=93 Participants	1610 Participants n=4 Participants	3224 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Country Botswana	46 Participants n=93 Participants	45 Participants n=4 Participants	91 Participants n=27 Participants
Country Kenya	31 Participants n=93 Participants	35 Participants n=4 Participants	66 Participants n=27 Participants
Country Malawi	113 Participants n=93 Participants	111 Participants n=4 Participants	224 Participants n=27 Participants
Country South Africa	653 Participants n=93 Participants	655 Participants n=4 Participants	1308 Participants n=27 Participants
Country Swaziland	80 Participants n=93 Participants	80 Participants n=4 Participants	160 Participants n=27 Participants
Country Uganda	300 Participants n=93 Participants	296 Participants n=4 Participants	596 Participants n=27 Participants
Country Zimbabwe	391 Participants n=93 Participants	388 Participants n=4 Participants	779 Participants n=27 Participants
Race American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race Asian	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race Black or African American	1612 Participants n=93 Participants	1606 Participants n=4 Participants	3218 Participants n=27 Participants
Race Mixed Race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race White	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: HIV tests at enrollment, weeks 2, 4, and 5, then every 4 weeks through week 25, then every 8 weeks. Analyzed through week 185 or the date of DSMB decision to unblind all participants, whichever is earliest.

Population: All enrolled participants

The number of participants with an incident HIV infection that is confirmed by the HPTN Laboratory Center and Endpoint Adjudication Committee.

Outcome measures

Measure	Arm A: CAB + Placebo TDF/FTC + CAB LA n=1614 Participants During Step 1, participants will receive daily oral CAB and oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral CAB: CAB 30 mg tablet Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral TDF/FTC: Placebo tablets CAB LA: 600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle	Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA n=1610 Participants During Step 1, participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks. In Step 2, participants will receive daily TDF/FTC and placebo for CAB LA injections at two times points 4 weeks apart and every 8 weeks thereafter beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral CAB: Placebo tablets Placebo for CAB LA: Administered as one 3 mL intramuscular injection in the gluteal muscle
Number of Pariicipants With Documented Incident HIV Infections	4 Participants	36 Participants

PRIMARY outcome

Timeframe: Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks)

Population: All enrolled participants

AEs will be summarized using MedDRA System Organ Class and preferred terms.

Outcome measures

Measure	Arm A: CAB + Placebo TDF/FTC + CAB LA n=1614 Participants During Step 1, participants will receive daily oral CAB and oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral CAB: CAB 30 mg tablet Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral TDF/FTC: Placebo tablets CAB LA: 600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle	Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA n=1610 Participants During Step 1, participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks. In Step 2, participants will receive daily TDF/FTC and placebo for CAB LA injections at two times points 4 weeks apart and every 8 weeks thereafter beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral CAB: Placebo tablets Placebo for CAB LA: Administered as one 3 mL intramuscular injection in the gluteal muscle
Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2	1487 Participants	1486 Participants

Adverse Events

Arm A: CAB + Placebo TDF/FTC + CAB LA

Serious events: 33 serious events

Other events: 1486 other events

Deaths: 3 deaths

Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA

Serious events: 33 serious events

Other events: 1486 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A: CAB + Placebo TDF/FTC + CAB LA n=1614 participants at risk During Step 1, participants will receive daily oral CAB and oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral CAB: CAB 30 mg tablet Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral TDF/FTC: Placebo tablets CAB LA: 600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle	Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA n=1610 participants at risk During Step 1, participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks. In Step 2, participants will receive daily TDF/FTC and placebo for CAB LA injections at two times points 4 weeks apart and every 8 weeks thereafter beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral CAB: Placebo tablets Placebo for CAB LA: Administered as one 3 mL intramuscular injection in the gluteal muscle
Infections and infestations Endometritis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Escherichia pyelonephritis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gastritis bacterial	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Any Event in SOC	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Hypersplenism	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Cardiac disorders Any Event in SOC	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Cardiac disorders Hypertensive heart disease	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Any Event in SOC	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Peptic ulcer	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Hepatobiliary disorders Any Event in SOC	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Hepatobiliary disorders Hepatitis acute	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Any Event in SOC	0.74% 12/1614 • Number of events 13 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Appendiceal abscess	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bartholin's abscess	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations COVID-19	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Hepatitis A	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Malaria	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pelvic inflammatory disease	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Peritonsillar abscess	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pneumonia bacterial	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pulmonary tuberculosis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Respiratory tract infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tonsillitis bacterial	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Urinary tract infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Any Event in SOC	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Arthropod sting	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Head injury	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Post concussion syndrome	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Soft tissue injury	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Stab wound	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Alanine aminotransferase increased	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Any Event in SOC	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Aspartate aminotransferase increased	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood creatine phosphokinase increased	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Any Event in SOC	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Any Event in SOC	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Any Event in SOC	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Any Event in SOC	0.12% 2/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Cerebrovascular accident	0.06% 1/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Headache	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Seizure	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Any Event in SOC	0.50% 8/1614 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Anxiety	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Any Event in SOC	0.19% 3/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Depression	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Intentional self-injury	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Major depression	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Panic disorder	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Psychotic disorder	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Suicide attempt	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Any Event in SOC	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.

Other adverse events

Measure	Arm A: CAB + Placebo TDF/FTC + CAB LA n=1614 participants at risk During Step 1, participants will receive daily oral CAB and oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive injections of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral CAB: CAB 30 mg tablet Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral TDF/FTC: Placebo tablets CAB LA: 600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle	Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA n=1610 participants at risk During Step 1, participants will receive daily TDF/FTC and oral CAB placebo for 5 weeks. In Step 2, participants will receive daily TDF/FTC and placebo for CAB LA injections at two times points 4 weeks apart and every 8 weeks thereafter beginning at Week 5. In Step 3, participants will receive daily TDF/FTC for up to 48 weeks, starting no later than 8 weeks after the last injection. Oral TDF/FTC: TDF/FTC 300 mg/200 mg fixed dose combination tablet Placebo for oral CAB: Placebo tablets Placebo for CAB LA: Administered as one 3 mL intramuscular injection in the gluteal muscle
Eye disorders Visual impairment	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Abdominal discomfort	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Abdominal distension	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Abdominal pain	2.5% 41/1614 • Number of events 42 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.5% 41/1610 • Number of events 45 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Anaemia	0.19% 3/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Any Event in SOC	2.5% 40/1614 • Number of events 54 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.7% 27/1610 • Number of events 28 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Eosinophilia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Hypochromic anaemia	0.12% 2/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Iron deficiency anaemia	0.25% 4/1614 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Leukopenia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Lymphadenitis	0.12% 2/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Lymphadenopathy	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Microcytic anaemia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Neutropenia	1.4% 22/1614 • Number of events 26 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.56% 9/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Blood and lymphatic system disorders Thrombocytopenia	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Cardiac disorders Any Event in SOC	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Cardiac disorders Palpitations	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Cardiac disorders Rheumatic heart disease	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Cardiac disorders Tachycardia	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Ear and labyrinth disorders Any Event in SOC	0.56% 9/1614 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Ear and labyrinth disorders Cerumen impaction	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Ear and labyrinth disorders Ear pain	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Ear and labyrinth disorders Ear pruritus	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Ear and labyrinth disorders Eustachian tube obstruction	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Ear and labyrinth disorders Excessive cerumen production	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Ear and labyrinth disorders Otorrhoea	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Ear and labyrinth disorders Tympanic membrane perforation	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Endocrine disorders Any Event in SOC	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Endocrine disorders Goitre	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Any Event in SOC	2.9% 47/1614 • Number of events 59 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.4% 38/1610 • Number of events 42 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Asthenopia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Blepharitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Blindness unilateral	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Chalazion	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Conjunctival haemorrhage	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Conjunctivitis allergic	1.9% 31/1614 • Number of events 40 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.4% 23/1610 • Number of events 26 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Dry eye	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Eye allergy	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Eye pain	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Eye pruritus	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Eyelid cyst	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Periorbital swelling	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Photophobia	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Pingueculitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Refraction disorder	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Scleritis allergic	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Eye disorders Vernal keratoconjunctivitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Abdominal pain lower	1.2% 19/1614 • Number of events 19 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.4% 23/1610 • Number of events 23 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Abdominal pain upper	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Acute abdomen	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Anal fissure	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Anal pruritus	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Any Event in SOC	20.7% 334/1614 • Number of events 487 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	22.9% 369/1610 • Number of events 574 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Aphthous ulcer	0.12% 2/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Breath odour	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Constipation	1.1% 18/1614 • Number of events 19 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.4% 22/1610 • Number of events 25 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Dental caries	2.1% 34/1614 • Number of events 36 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	3.2% 51/1610 • Number of events 52 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Diarrhoea	3.5% 56/1614 • Number of events 61 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	3.3% 53/1610 • Number of events 56 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Duodenitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Dyspepsia	3.8% 61/1614 • Number of events 82 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	4.4% 71/1610 • Number of events 80 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Enteritis	0.37% 6/1614 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.81% 13/1610 • Number of events 13 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Food poisoning	0.62% 10/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.43% 7/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Frequent bowel movements	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Gastritis	4.2% 67/1614 • Number of events 77 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	4.1% 66/1610 • Number of events 79 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.2% 19/1614 • Number of events 22 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.2% 20/1610 • Number of events 27 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Gingival pain	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Glossodynia	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Haemorrhoids	0.74% 12/1614 • Number of events 14 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.43% 7/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Hyperchlorhydria	0.50% 8/1614 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 17 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Lip blister	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Lip swelling	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Mouth ulceration	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Nausea	1.1% 18/1614 • Number of events 19 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.5% 41/1610 • Number of events 45 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Peptic ulcer	0.43% 7/1614 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.50% 8/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Proctalgia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Proctitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Stomatitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Tooth disorder	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Tooth impacted	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Toothache	1.3% 21/1614 • Number of events 24 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.6% 25/1610 • Number of events 25 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Gastrointestinal disorders Vomiting	0.68% 11/1614 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.8% 29/1610 • Number of events 30 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Any Event in SOC	4.6% 75/1614 • Number of events 85 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	5.8% 94/1610 • Number of events 102 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Chills	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Complication of device removal	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Facial pain	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Fatigue	0.87% 14/1614 • Number of events 15 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.81% 13/1610 • Number of events 14 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Implant site induration	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Implant site pain	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Influenza like illness	2.3% 37/1614 • Number of events 40 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.7% 44/1610 • Number of events 47 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Malaise	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Medical device pain	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Non-cardiac chest pain	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Oedema peripheral	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Pain	0.31% 5/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Peripheral swelling	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Pyrexia	0.43% 7/1614 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.62% 10/1610 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Suprapubic pain	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Swelling	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Swelling face	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
General disorders Vessel puncture site pain	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Hepatobiliary disorders Any Event in SOC	0.12% 2/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Hepatobiliary disorders Hyperbilirubinaemia	0.12% 2/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Hepatobiliary disorders Liver disorder	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Immune system disorders Allergy to arthropod bite	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Immune system disorders Any Event in SOC	2.1% 34/1614 • Number of events 40 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.3% 37/1610 • Number of events 48 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Immune system disorders Atopy	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Immune system disorders Drug hypersensitivity	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Immune system disorders Food allergy	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Immune system disorders Hypersensitivity	0.37% 6/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.50% 8/1610 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Immune system disorders Multiple allergies	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Immune system disorders Seasonal allergy	1.5% 25/1614 • Number of events 31 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.6% 26/1610 • Number of events 32 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Abdominal infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Abortion infected	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Abscess	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Abscess bacterial	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Abscess limb	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.56% 9/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Abscess neck	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Abscess oral	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Acarodermatitis	0.99% 16/1614 • Number of events 18 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.62% 10/1610 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Acne pustular	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Acute sinusitis	0.31% 5/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Amoebiasis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Anal abscess	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Any Event in SOC	61.0% 985/1614 • Number of events 2797 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	61.3% 987/1610 • Number of events 2775 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Arthritis bacterial	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bacteraemia	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bacterial abdominal infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bacterial blepharitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bacterial diarrhoea	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bacterial rhinitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bacterial vaginosis	2.4% 38/1614 • Number of events 43 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.2% 36/1610 • Number of events 41 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bacteriuria	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bartholin's abscess	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bartholinitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Body tinea	2.7% 44/1614 • Number of events 56 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.1% 34/1610 • Number of events 43 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bronchitis	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Bronchitis viral	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Burn infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations COVID-19	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Candida infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Carbuncle	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Cellulitis	0.62% 10/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Cervicitis	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Chancroid	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Chlamydial infection	7.1% 115/1614 • Number of events 126 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	8.8% 141/1610 • Number of events 159 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Chronic sinusitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Conjunctivitis	1.7% 27/1614 • Number of events 33 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.8% 29/1610 • Number of events 35 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Conjunctivitis bacterial	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Cystitis	0.43% 7/1614 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Cystitis bacterial	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Dermatitis infected	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Dermatophytosis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Diarrhoea infectious	0.25% 4/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Dysentery	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Ear infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Ear infection fungal	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Endometritis	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Enteritis infectious	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Escherichia urinary tract infection	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Eye abscess	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Eye infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Eyelid infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Febrile infection	0.50% 8/1614 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.43% 7/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Folliculitis	1.2% 19/1614 • Number of events 20 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.87% 14/1610 • Number of events 15 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Fungal infection	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Fungal skin infection	1.9% 31/1614 • Number of events 33 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.6% 26/1610 • Number of events 28 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Furuncle	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gastric infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gastritis bacterial	0.37% 6/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.43% 7/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gastroenteritis	4.8% 77/1614 • Number of events 97 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	4.6% 74/1610 • Number of events 84 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gastroenteritis bacterial	1.8% 29/1614 • Number of events 35 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.7% 28/1610 • Number of events 32 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gastroenteritis shigella	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gastroenteritis viral	0.12% 2/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genital abscess	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genital candidiasis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genital herpes	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.43% 7/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genital herpes simplex	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genital infection	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genital infection fungal	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genital ulcer syndrome	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genitourinary chlamydia infection	9.0% 146/1614 • Number of events 169 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	9.4% 151/1610 • Number of events 172 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genitourinary tract gonococcal infection	4.2% 67/1614 • Number of events 71 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	4.3% 69/1610 • Number of events 77 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Genitourinary tract infection	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gingivitis	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.50% 8/1610 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gonococcal infection	2.4% 39/1614 • Number of events 40 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.5% 41/1610 • Number of events 43 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Gonorrhoea	1.2% 20/1614 • Number of events 20 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.99% 16/1610 • Number of events 17 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Groin abscess	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Helicobacter gastritis	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Helicobacter infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Helminthic infection	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Hepatitis A	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Hepatitis C	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Herpes simplex	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Herpes virus infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Hordeolum	0.37% 6/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Impetigo	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Implant site infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Infected cyst	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Infected skin ulcer	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Influenza	1.9% 30/1614 • Number of events 31 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.4% 22/1610 • Number of events 23 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Laryngitis	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Laryngitis viral	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Localised infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Lower respiratory tract infection	0.43% 7/1614 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Lower respiratory tract infection bacterial	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Lymphadenitis bacterial	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Malaria	3.1% 50/1614 • Number of events 51 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	3.9% 63/1610 • Number of events 79 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Mastitis	0.43% 7/1614 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Molluscum contagiosum	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Mumps	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Nasopharyngitis	4.6% 75/1614 • Number of events 108 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	5.3% 86/1610 • Number of events 133 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Nematodiasis	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Onychomycosis	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Oral bacterial infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Oral candidiasis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Oral herpes	0.74% 12/1614 • Number of events 13 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.62% 10/1610 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Oral infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Oropharyngeal candidiasis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Otitis externa	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Otitis externa bacterial	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Otitis media	0.62% 10/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.50% 8/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Otitis media acute	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Otitis media bacterial	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Otitis media chronic	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Papilloma viral infection	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Parasitic gastroenteritis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Paronychia	0.37% 6/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Parotitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pelvic infection	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pelvic inflammatory disease	3.2% 52/1614 • Number of events 58 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.7% 44/1610 • Number of events 57 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Peptic ulcer helicobacter	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Perineal abscess	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Periodontitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Peritonitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pharyngitis	1.6% 26/1614 • Number of events 28 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.1% 17/1610 • Number of events 20 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pharyngitis bacterial	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Plasmodium falciparum infection	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pneumonia	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Post procedural infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Post procedural sepsis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pulmonary tuberculosis	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pulpitis dental	0.81% 13/1614 • Number of events 16 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pustule	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pyelonephritis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pyelonephritis acute	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Pyometra	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Rash pustular	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Respiratory tract infection	2.4% 38/1614 • Number of events 43 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.6% 26/1610 • Number of events 28 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Respiratory tract infection viral	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Rhinitis	1.7% 27/1614 • Number of events 29 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.2% 20/1610 • Number of events 22 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Rhinovirus infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Salmonellosis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Salpingitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Schistosomiasis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Secondary syphilis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Sexually transmitted disease	2.2% 35/1614 • Number of events 38 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.8% 45/1610 • Number of events 48 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Sinusitis	0.93% 15/1614 • Number of events 18 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 13 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Sinusitis bacterial	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Skin bacterial infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Skin candida	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Skin infection	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Streptococcal infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Streptococcal urinary tract infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Subcutaneous abscess	1.1% 17/1614 • Number of events 18 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.6% 26/1610 • Number of events 30 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Syphilis	1.9% 30/1614 • Number of events 32 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.6% 26/1610 • Number of events 27 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Syphilis genital	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tinea capitis	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tinea cruris	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tinea faciei	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tinea infection	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tinea manuum	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tinea pedis	0.43% 7/1614 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tinea versicolour	1.5% 25/1614 • Number of events 27 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.1% 18/1610 • Number of events 20 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tonsillitis	3.9% 63/1614 • Number of events 71 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.9% 47/1610 • Number of events 52 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tonsillitis bacterial	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tooth abscess	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tooth infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Trichomoniasis	1.2% 20/1614 • Number of events 23 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tuberculous pleurisy	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Tubo-ovarian abscess	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Typhoid fever	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Upper respiratory tract infection	14.9% 240/1614 • Number of events 381 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	17.0% 274/1610 • Number of events 403 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Upper respiratory tract infection bacterial	0.68% 11/1614 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.81% 13/1610 • Number of events 14 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Urinary tract candidiasis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Urinary tract infection	13.6% 219/1614 • Number of events 347 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	12.6% 203/1610 • Number of events 316 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Urinary tract infection bacterial	0.68% 11/1614 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.43% 7/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Urinary tract infection enterococcal	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Urogenital trichomoniasis	0.93% 15/1614 • Number of events 15 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Vaginal abscess	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Vaginal infection	1.7% 27/1614 • Number of events 31 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.6% 25/1610 • Number of events 30 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Vaginitis chlamydial	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Varicella	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Varicella zoster virus infection	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Viral infection	0.37% 6/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Viral parotitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Viral pharyngitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Viral rhinitis	0.62% 10/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.81% 13/1610 • Number of events 16 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Viral sinusitis	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Viral tonsillitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Viral upper respiratory tract infection	2.1% 34/1614 • Number of events 40 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.4% 38/1610 • Number of events 43 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Vulvovaginal candidiasis	7.9% 127/1614 • Number of events 153 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	9.3% 150/1610 • Number of events 188 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Vulvovaginal mycotic infection	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Vulvovaginitis	0.74% 12/1614 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.56% 9/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Vulvovaginitis trichomonal	7.7% 124/1614 • Number of events 146 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	6.8% 109/1610 • Number of events 125 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Wound infection	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Infections and infestations Wound sepsis	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Animal bite	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Ankle fracture	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Any Event in SOC	6.7% 108/1614 • Number of events 129 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	7.6% 122/1610 • Number of events 136 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Arthropod bite	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Arthropod sting	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Back injury	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Contusion	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Electrical burn	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Eye contusion	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Eye injury	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Eyelid contusion	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Face injury	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Human bite	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Iliotibial band syndrome	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Inflammation of wound	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Injury	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Joint injury	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Ligament sprain	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.56% 9/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Limb injury	0.56% 9/1614 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Muscle strain	0.87% 14/1614 • Number of events 16 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Periorbital haematoma	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Post procedural swelling	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Post-traumatic pain	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Procedural pain	0.87% 14/1614 • Number of events 14 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.93% 15/1610 • Number of events 15 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Rib fracture	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Skin abrasion	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Skin laceration	0.68% 11/1614 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.43% 7/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Skin wound	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Soft tissue injury	1.1% 17/1614 • Number of events 17 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.7% 27/1610 • Number of events 29 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Stab wound	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Sunburn	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Thermal burn	0.37% 6/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Traumatic arthritis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Traumatic ulcer	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Upper limb fracture	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Vulvovaginal injury	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Injury, poisoning and procedural complications Wound	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Alanine aminotransferase increased	3.2% 51/1614 • Number of events 56 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	3.0% 49/1610 • Number of events 57 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Amylase increased	10.5% 169/1614 • Number of events 217 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	9.3% 149/1610 • Number of events 202 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Any Event in SOC	81.0% 1307/1614 • Number of events 4437 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	82.7% 1331/1610 • Number of events 4502 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Aspartate aminotransferase increased	2.5% 40/1614 • Number of events 51 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.4% 39/1610 • Number of events 44 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood alkaline phosphatase increased	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood bicarbonate decreased	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood bilirubin increased	0.74% 12/1614 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.2% 19/1610 • Number of events 25 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood calcium decreased	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood calcium increased	0.81% 13/1614 • Number of events 13 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood cholesterol increased	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood creatine increased	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood creatine phosphokinase increased	5.3% 85/1614 • Number of events 92 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	4.2% 67/1610 • Number of events 72 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood creatinine decreased	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood creatinine increased	21.1% 340/1614 • Number of events 610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	20.5% 330/1610 • Number of events 566 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood glucose decreased	9.0% 146/1614 • Number of events 180 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	9.1% 146/1610 • Number of events 178 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood glucose increased	4.6% 75/1614 • Number of events 98 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	3.1% 50/1610 • Number of events 66 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood phosphorus decreased	3.6% 58/1614 • Number of events 68 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	5.2% 83/1610 • Number of events 104 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood phosphorus increased	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood pressure diastolic increased	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood pressure increased	0.87% 14/1614 • Number of events 24 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.81% 13/1610 • Number of events 14 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood pressure systolic increased	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Blood triglycerides increased	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Creatinine renal clearance decreased	72.2% 1166/1614 • Number of events 2812 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	74.3% 1197/1610 • Number of events 2981 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Creatinine renal clearance increased	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Gastric pH decreased	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Glucose urine present	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Haemoglobin decreased	1.3% 21/1614 • Number of events 24 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.2% 20/1610 • Number of events 25 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Lipase increased	3.2% 52/1614 • Number of events 72 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	3.2% 52/1610 • Number of events 68 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Low density lipoprotein increased	0.74% 12/1614 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Lymphocyte count decreased	0.56% 9/1614 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Neutrophil count decreased	1.2% 19/1614 • Number of events 22 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.2% 20/1610 • Number of events 27 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Platelet count decreased	0.99% 16/1614 • Number of events 20 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.56% 9/1610 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Protein urine present	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Red blood cells urine positive	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Urobilinogen urine increased	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Weight decreased	0.50% 8/1614 • Number of events 14 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.56% 9/1610 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations Weight increased	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Investigations White blood cell count decreased	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Abnormal loss of weight	5.3% 85/1614 • Number of events 110 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	6.6% 107/1610 • Number of events 167 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Abnormal weight gain	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Any Event in SOC	9.5% 154/1614 • Number of events 200 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	12.0% 194/1610 • Number of events 285 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Decreased appetite	2.1% 34/1614 • Number of events 38 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	3.8% 61/1610 • Number of events 67 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Diabetes mellitus	0.37% 6/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Gout	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Hyperglycaemia	0.68% 11/1614 • Number of events 17 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.81% 13/1610 • Number of events 13 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Hypoglycaemia	0.93% 15/1614 • Number of events 17 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.2% 19/1610 • Number of events 22 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Hypophosphataemia	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Increased appetite	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Polydipsia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Starvation	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.12% 2/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Any Event in SOC	14.3% 230/1614 • Number of events 335 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	13.7% 220/1610 • Number of events 323 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 34/1614 • Number of events 37 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.4% 39/1610 • Number of events 40 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Arthritis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Back pain	6.6% 106/1614 • Number of events 130 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	7.0% 112/1610 • Number of events 137 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Bursitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Costochondritis	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.43% 7/1610 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Extremity contracture	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Flank pain	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Joint effusion	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Joint stiffness	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Muscle spasms	0.62% 10/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.56% 9/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Muscle tightness	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.4% 23/1614 • Number of events 27 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.3% 21/1610 • Number of events 23 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.7% 43/1614 • Number of events 47 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.2% 35/1610 • Number of events 43 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Myalgia	1.7% 28/1614 • Number of events 32 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.3% 21/1610 • Number of events 21 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Neck pain	0.37% 6/1614 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Ochronosis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 18/1614 • Number of events 22 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.99% 16/1610 • Number of events 19 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Polyarthritis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Synovial cyst	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Tendonitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Torticollis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Musculoskeletal and connective tissue disorders Vertebral osteophyte	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Any Event in SOC	0.43% 7/1614 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.50% 8/1610 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Conjunctival neoplasm	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.12% 2/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Any Event in SOC	19.1% 309/1614 • Number of events 423 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	19.3% 311/1610 • Number of events 467 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Cluster headache	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Dizziness	0.62% 10/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.75% 12/1610 • Number of events 13 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Dysgeusia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Headache	13.8% 222/1614 • Number of events 283 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	13.8% 222/1610 • Number of events 310 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Hypoaesthesia	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Migraine	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Neuralgia	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Neuritis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Neuropathy peripheral	0.43% 7/1614 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.50% 8/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Paraesthesia	0.87% 14/1614 • Number of events 16 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.3% 21/1610 • Number of events 22 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Poor quality sleep	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Post-traumatic headache	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Psychogenic seizure	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Sciatica	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Sensory disturbance	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Sinus headache	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Somnolence	0.25% 4/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Syncope	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Nervous system disorders Tension headache	3.8% 62/1614 • Number of events 82 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	4.3% 70/1610 • Number of events 90 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Any Event in SOC	0.43% 7/1614 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Morning sickness	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Pregnancy, puerperium and perinatal conditions Retained products of conception	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Product Issues Any Event in SOC	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Product Issues Device dislocation	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Abnormal dreams	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Alcohol abuse	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Alcohol use disorder	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Anger	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Anxiety	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Any Event in SOC	2.0% 32/1614 • Number of events 39 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.9% 31/1610 • Number of events 35 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Depression	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Depression suicidal	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Depressive symptom	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Emotional distress	0.37% 6/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Grief reaction	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Insomnia	0.68% 11/1614 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.75% 12/1610 • Number of events 14 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Major depression	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Panic attack	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Panic disorder	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Pica	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Post-traumatic stress disorder	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Sleep disorder	0.06% 1/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Stress	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Substance use disorder	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Psychiatric disorders Suicidal ideation	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Renal and urinary disorders Any Event in SOC	1.1% 18/1614 • Number of events 19 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.2% 20/1610 • Number of events 21 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Renal and urinary disorders Dysuria	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Renal and urinary disorders Glycosuria	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Renal and urinary disorders Haematuria	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Renal and urinary disorders Polyuria	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Renal and urinary disorders Proteinuria	0.62% 10/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Renal and urinary disorders Renal mass	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Renal and urinary disorders Urine odour abnormal	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Abnormal withdrawal bleeding	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Amenorrhoea	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Any Event in SOC	27.0% 435/1614 • Number of events 734 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	26.0% 419/1610 • Number of events 727 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Breast mass	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Breast pain	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Breast swelling	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Cervical discharge	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Cervical friability	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Cervical polyp	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Cervix disorder	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Coital bleeding	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Dysfunctional uterine bleeding	9.3% 150/1614 • Number of events 230 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	9.1% 146/1610 • Number of events 212 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Dysmenorrhoea	2.7% 44/1614 • Number of events 51 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	3.8% 61/1610 • Number of events 72 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Dyspareunia	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Endometrial hyperplasia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Endometriosis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Genital rash	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Genital ulceration	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Mammary duct ectasia	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Menometrorrhagia	1.2% 20/1614 • Number of events 27 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.1% 18/1610 • Number of events 23 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Menorrhagia	5.6% 91/1614 • Number of events 110 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	5.7% 91/1610 • Number of events 133 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Menstruation irregular	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Metrorrhagia	5.7% 92/1614 • Number of events 119 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	5.2% 84/1610 • Number of events 110 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Nipple disorder	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Nipple exudate bloody	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Ovarian mass	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Pelvic pain	0.74% 12/1614 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.56% 9/1610 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Polycystic ovaries	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Polymenorrhoea	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Premenstrual pain	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Premenstrual syndrome	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Uterine cervical pain	0.31% 5/1614 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.43% 7/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Uterine spasm	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Vaginal discharge	5.1% 83/1614 • Number of events 103 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	3.6% 58/1610 • Number of events 90 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Vaginal haemorrhage	0.87% 14/1614 • Number of events 15 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Vaginal ulceration	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Vulval ulceration	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Vulvovaginal burning sensation	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Vulvovaginal discomfort	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Vulvovaginal pruritus	1.5% 25/1614 • Number of events 32 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.4% 22/1610 • Number of events 25 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Reproductive system and breast disorders Vulvovaginitis allergic	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Allergic bronchitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Allergic cough	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Allergic pharyngitis	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	0.50% 8/1614 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Any Event in SOC	5.3% 85/1614 • Number of events 97 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	4.8% 77/1610 • Number of events 97 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Asthma	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 19/1614 • Number of events 20 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.1% 18/1610 • Number of events 19 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.2% 19/1614 • Number of events 20 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.81% 13/1610 • Number of events 14 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Nasal ulcer	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.37% 6/1614 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.50% 8/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.5% 25/1614 • Number of events 26 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.1% 17/1610 • Number of events 22 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.19% 3/1614 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Tonsillar inflammation	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Acne	1.1% 17/1614 • Number of events 19 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.87% 14/1610 • Number of events 14 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Any Event in SOC	11.6% 187/1614 • Number of events 234 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	9.8% 157/1610 • Number of events 207 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Blister	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Cold urticaria	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Dermal cyst	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Dermatitis	1.5% 25/1614 • Number of events 26 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.87% 14/1610 • Number of events 15 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Dermatitis allergic	2.1% 34/1614 • Number of events 36 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	2.5% 40/1610 • Number of events 47 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Dermatitis contact	0.56% 9/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 7 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Drug eruption	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Dry skin	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.31% 5/1610 • Number of events 5 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Eczema	0.43% 7/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.68% 11/1610 • Number of events 12 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Hangnail	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Intertrigo	0.12% 2/1614 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Prurigo	0.68% 11/1614 • Number of events 13 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.37% 6/1610 • Number of events 6 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Pruritus	1.9% 30/1614 • Number of events 36 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.7% 28/1610 • Number of events 30 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Pruritus allergic	0.25% 4/1614 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Rash	1.3% 21/1614 • Number of events 23 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.2% 20/1610 • Number of events 20 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Rash erythematous	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Rash follicular	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Rash macular	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Rash papular	0.62% 10/1614 • Number of events 11 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.56% 9/1610 • Number of events 9 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Rash pruritic	0.50% 8/1614 • Number of events 8 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.25% 4/1610 • Number of events 4 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Scar pain	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Skin burning sensation	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Skin discolouration	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Skin ulcer	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Skin and subcutaneous tissue disorders Urticaria	1.1% 17/1614 • Number of events 18 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.1% 17/1610 • Number of events 17 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Social circumstances Any Event in SOC	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.19% 3/1610 • Number of events 3 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Social circumstances Victim of crime	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Social circumstances Victim of sexual abuse	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Vascular disorders Any Event in SOC	0.81% 13/1614 • Number of events 13 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.4% 22/1610 • Number of events 23 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Vascular disorders Diastolic hypertension	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Vascular disorders Essential hypertension	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.06% 1/1610 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Vascular disorders Hypertension	0.62% 10/1614 • Number of events 10 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	1.2% 20/1610 • Number of events 20 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Vascular disorders Hypotension	0.00% 0/1614 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.12% 2/1610 • Number of events 2 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.
Vascular disorders Phlebitis	0.06% 1/1614 • Number of events 1 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.	0.00% 0/1610 • Treatment emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Adverse events are not reported separately for Step 1 (oral lead-in), Step 2 (CAB-LA injections or oral TDF/FTC) and Step 3 (open-label TDF/FTC) as an AE may not be reliably attributed to a specific step in the sequence.

Additional Information

HPTN Statistical Manager

HPTN Statistical & Data Management Center

Phone: 206-667-4004

Email: HPTN-Data-Access@scharp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place