Trial Outcomes & Findings for Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults (NCT NCT02605954)

Last Updated: 2018-11-14

Results Overview

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

275 participants

Primary outcome timeframe

Week 24

Results posted on

2018-11-14

Participant Flow

Participants were enrolled at study sites in Europe and North America. The first participant was screened on 18 November 2015. The last study visit occurred on 24 Jan 2018.

346 participants were screened.

Participant milestones

Participant milestones
Measure	E/C/F/TAF Elvitegravir/ cobicistat/ emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg fixed dose combination (FDC) tablets administered orally once daily with food for 48 weeks	ABC/3TC+3rd Agent Abacavir/lamivudine (ABC/3TC) 600/300 mg tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC
Overall Study STARTED	183	92
Overall Study COMPLETED	171	88
Overall Study NOT COMPLETED	12	4

Reasons for withdrawal

Reasons for withdrawal
Measure	E/C/F/TAF Elvitegravir/ cobicistat/ emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg fixed dose combination (FDC) tablets administered orally once daily with food for 48 weeks	ABC/3TC+3rd Agent Abacavir/lamivudine (ABC/3TC) 600/300 mg tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC
Overall Study Adverse Event	5	1
Overall Study Investigator's Discretion	1	0
Overall Study Non-Compliance with Study Drug	1	0
Overall Study Withdrew Consent	2	2
Overall Study Lost to Follow-up	3	0
Overall Study Randomized but not treated	0	1

Baseline Characteristics

Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	E/C/F/TAF n=183 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks	ABC/3TC+3rd Agent n=91 Participants ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC	Total n=274 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 11.6 • n=5 Participants	49 years STANDARD_DEVIATION 10.7 • n=7 Participants	49 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	17 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	156 Participants n=5 Participants	74 Participants n=7 Participants	230 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Black	27 Participants n=5 Participants	15 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized White	150 Participants n=5 Participants	75 Participants n=7 Participants	225 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	27 Participants n=5 Participants	16 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	155 Participants n=5 Participants	73 Participants n=7 Participants	228 Participants n=5 Participants
Race/Ethnicity, Customized Not Permitted	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	19 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment Italy	43 Participants n=5 Participants	16 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment United Kingdom	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment France	40 Participants n=5 Participants	23 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment Germany	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Spain	56 Participants n=5 Participants	30 Participants n=7 Participants	86 Participants n=5 Participants
HIV-1 RNA Categories < 50 copies/mL	177 Participants n=5 Participants	91 Participants n=7 Participants	268 Participants n=5 Participants
HIV-1 RNA Categories 50 ≥ copies/mL	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
CD4 Cell Count	701 cells/µL STANDARD_DEVIATION 280.1 • n=5 Participants	753 cells/µL STANDARD_DEVIATION 312.8 • n=7 Participants	718 cells/µL STANDARD_DEVIATION 291.8 • n=5 Participants
CD4 Cell Count Category ≥ 50 to < 200 cells/µL	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
CD4 Cell Count Category ≥ 200 to < 350 cells/µL	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
CD4 Cell Count Category ≥ 350 to < 500 cells/µL	30 Participants n=5 Participants	13 Participants n=7 Participants	43 Participants n=5 Participants
CD4 Cell Count Category ≥ 500 cells/µL	140 Participants n=5 Participants	71 Participants n=7 Participants	211 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Full Analysis Set: participants who were randomized and received at least one dose of study drug (either E/C/F/TAF or ABC/3TC+3rd agent on or after Day 1).

Outcome measures

Outcome measures
Measure	E/C/F/TAF n=183 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks	ABC/3TC+3rd Agent n=91 Participants ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC	Delayed E/C/F/TAF n=89 Participants Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food.
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24	93.4 percentage of participants	97.8 percentage of participants	96.6 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Outcome measures
Measure	E/C/F/TAF n=183 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks	ABC/3TC+3rd Agent n=91 Participants ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC	Delayed E/C/F/TAF n=89 Participants Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food.
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12	95.1 percentage of participants	98.9 percentage of participants	96.6 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Only the participants who were randomized to E/C/F/TAF group were analyzed.

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Outcome measures
Measure	E/C/F/TAF n=183 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks	ABC/3TC+3rd Agent ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC	Delayed E/C/F/TAF Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food.
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 48	86.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF n=169 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks	ABC/3TC+3rd Agent n=90 Participants ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC	Delayed E/C/F/TAF n=86 Participants Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food.
Change From Baseline in CD4+ Cell Count at Week 24	-28 cells/µL Standard Deviation 161.4	8 cells/µL Standard Deviation 192.9	-23 cells/µL Standard Deviation 201.7

SECONDARY outcome

Timeframe: Baseline; Week 48

Population: Participants in the E/C/F/TAF group with available data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF n=156 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks	ABC/3TC+3rd Agent ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC	Delayed E/C/F/TAF Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food.
Change From Baseline in CD4+ Cell Count at Week 48	-32 cells/µL Standard Deviation 147.1	—	—

Adverse Events

E/C/F/TAF

Serious events: 12 serious events

Other events: 71 other events

Deaths: 0 deaths

ABC/3TC+3rd Agent

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Delayed E/C/F/TAF

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

All E/C/F/TAF

Serious events: 16 serious events

Other events: 88 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	E/C/F/TAF n=183 participants at risk E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily with food for 48 weeks	ABC/3TC+3rd Agent n=91 participants at risk ABC/3TC (600/300 mg) tablets plus a third antiretroviral agent administered orally once daily for 24 weeks followed by a delayed switch to E/C/F/TAF FDC	Delayed E/C/F/TAF n=89 participants at risk Participants in 'ABC/3TC+3rd agent' group who switched to E/C/F/TAF group at Week 24 received E/C/F/TAF (150/150/200/10 mg) FDC tablets orally once daily with food.	All E/C/F/TAF n=272 participants at risk Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF. Participants received E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food.
Gastrointestinal disorders Diarrhoea	10.4% 19/183 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	3.3% 3/91 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	4.5% 4/89 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	8.5% 23/272 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days
General disorders Asthenia	5.5% 10/183 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	1.1% 1/91 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	0.00% 0/89 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	3.7% 10/272 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days
Infections and infestations Upper respiratory tract infection	6.6% 12/183 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	5.5% 5/91 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	1.1% 1/89 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	4.8% 13/272 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days
Metabolism and nutrition disorders Vitamin D deficiency	7.1% 13/183 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	6.6% 6/91 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	0.00% 0/89 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	4.8% 13/272 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 11/183 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	2.2% 2/91 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	9.0% 8/89 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	7.0% 19/272 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days
Musculoskeletal and connective tissue disorders Back pain	3.3% 6/183 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	6.6% 6/91 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	2.2% 2/89 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	2.9% 8/272 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days
Nervous system disorders Headache	8.2% 15/183 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	4.4% 4/91 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	4.5% 4/89 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days	7.0% 19/272 • Up to 48 weeks plus 30 days The reported percentages in the Adverse Events table were not adjusted for the different durations in adverse events (AE) collection. By study design, the AE collection time frame for the treatment groups was as follows: * E/C/F/TAF group = 48 weeks plus 30 days * ABC/3TC+3rd Agent = 24 weeks * Delayed E/C/F/TAF group = 24 weeks plus 30 days

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER