FDA approves new therapy for people living with skin-discoloration disorder Vitiligo

FDA approves new therapy for people living with skin-discoloration disorder Vitiligo
FDA approves new therapy for people living with skin-discoloration disorder Vitiligo
Courtesy Berardo Rivas

(NEW YORK) — The U.S. Food and Drug Administration granted approval on Monday for Opzelura, which is the first topical JAK inhibitor cream for the treatment of vitiligo for people 12 and older.

Vitiligo, which research estimates that 1.9-2.8 million adults in the U.S. have, is an autoimmune disorder caused by antibodies that attack a person’s pigment-producing cells. This causes patches of skin to lose color and become almost chalk white.

“There’s a large unmet medical need here in vitiligo,” Dr. Steven Stein, chief medical officer at Incyte, told ABC News. “This opens a completely new door, new avenue for them and for patients who want therapy to repigment.”

“With the approval of Opzelura in nonsegmental vitiligo, Incyte has once again delivered a treatment to patients with high unmet medical need who previously had no approved therapies,” Hervé Hoppenot, Incyte’s chief executive officer, said in a press release. “We are proud of Incyte’s scientists and development teams that have made this milestone possible, and we’re pleased that eligible vitiligo patients now have a choice to address repigmentation.”

The discoloration doesn’t usually cause a medical risk but can result in physical complications, such as eye issues, hearing problems and severe sunburn. It also can be challenging to deal with people’s reactions.

“Growing up with vitiligo has been pretty hard. Going around people seeing you with white patches. It’s very stressful that people judge you from your skin,” Berardo Rivas, a 41-year-old who’s been living with vitiligo for over 30 years, told ABC News. “It was traumatizing growing up.”

Rivas said he had minimal success with other treatments prior to joining the clinical trial for Opzelura, but he told ABC News he first started to see positive results after four months and more noticeable results in 1 year.

“My wife looked at me. She stared at me and she’s said, you know, you have pigment back on your eyes and I was like, I didn’t believe her. So I ran straight to the mirror. And I saw it … I was just jumping with joy. It’s like, oh, it’s working. You know, thank God,” he said.

Vitiligo can’t be cured and it’s difficult to control. Oral and topical steroids are a common treatment for vitiligo before this FDA approval, but most are not a long term solution, experts told ABC News.

“Since long-term use of steroids has a lot of side effects, dermatologists are always looking for steroid-sparing agents.” Dr. Mansha Sethi, a board-certified dermatologist in Houston, who was not involved in the clinical trial, told ABC News.

Doctors may also try phototherapy, which stimulates cells to make skin pigment, but this option is not always easy to implement as it can be expensive and involves going into an office equipped with phototherapy devices multiple times a week, every week.

“Emerging topical JAK-inhibitors, like Ruxolitinib (Opzelura), are a promising option,” Sethi said. “I personally have used JAK inhibitors off-label for several patients with vitiligo. Since it’s off-label, patients have to spend hundreds of dollars out of pocket to buy them from compounding pharmacies.”

But now, with FDA approval, insurance companies are expected to begin covering this prescription drug.

It’s difficult to predict how much the medication will cost depending on the plan you have, but as is common with pharmaceuticals, Dr. Stein says that Incyte plans to “provide copay cards that will limit the out-of-pocket cost to patients to hopefully as little as $10 or less.” And the company has a program that some may qualify to get Opzelura for free called IncyteCARES.

Dr. David Rosmarin, director of the Clinical Trials Unit at Tufts, and the principal investigator for the Opzelura vitiligo clinical trials, told ABC News he started searching for better treatments in 2013.

“We realized that the immune system is too active destroying the pigment cells,” he said.

He wondered if, Opzelura, which was already FDA approved for the treatment of mild to moderate eczema, would be able to stop the immune system from attacking the pigment.

It works as a JAK1/JAK2 inhibitor that targets specific immune system pathways specific to vitiligo.

Opzelura was tested in two Phase 3 clinical trials, which enrolled over 600 men and women ages 12 and older.

Results of the trial showed “Adolescent and adult patients with vitiligo achieved substantial facial and total body re-pigmentation within 24 to 52 weeks of therapy.”

Half of all participants had 75% improvement of their facial vitiligo after one year using the study’s measurement of repigmentation.

Rosmarin said the side effects were well tolerated.

“Six percent of patients will get some acne, which is usually mild. And about 6% can have an application site reaction, which could be some redness,” Rosmarin said. “It has a very favorable safety profile, topical easy to use, and has proven to work very consistently.”

The medication requires a prescription and is applied as a cream to clean skin on areas affected by vitiligo twice a day.

Copyright © 2022, ABC Audio. All rights reserved.

Sparks fly at Uvalde school board forum as community demands transparency, accountability

Sparks fly at Uvalde school board forum as community demands transparency, accountability
Sparks fly at Uvalde school board forum as community demands transparency, accountability
Jordan Vonderhaar/Getty Images

(UVALDE, Texas) — Emotions reached a roiling boiling point Monday during an open forum hosted by the school board in Uvalde, Texas, just one day after a 77-page report by a joint committee of the Texas Legislature slammed the police response to the incident and the school district’s lack of preparation for such an attack.

A special public forum held by the Uvalde Consolidated Independent School District Board to allow community members to ask questions and voice concerns about the changes and updates for the 2022-2023 school year — including safety and security plans — quickly became a tinder box of emotion and anger.

Community members resoundingly said they want former Uvalde CISD Police Chief Pete Arredondo — currently on paid administrative leave — fired immediately. As the May 24 massacre unfolded, Arredondo allegedly failed to take on the role of incident commander or transfer the responsibility to another officer on scene, despite it being an “essential duty” he had assigned himself in the active shooter plan he helped write, the committee said.

Many called for members of Uvalde’s school district police force who were present during the shooting to be fired, for an independent investigation into the Robb Elementary School failures, and for answers and transparency about their specific concerns following the report.

On Monday night, parents threatened to pull their kids from Uvalde schools come September, and several also called for Uvalde CISD Superintendent Dr. Hal Harrell to resign.

The community also wanted answers on what was known about the Robb Elementary School door being locked or not.

“In violation of school policy, no one had locked any of the three exterior doors to the west building of Robb Elementary. As a result, the attacker had unimpeded access to enter,” the committee reported.

The committee also faulted the school district for failing to treat the maintenance of doors with known faulty locks with “appropriate urgency.”

Speakers at the forum also called for an independent investigation into the massacre. The group was united, calling several times to stand up together — to be courageous and voice their truth.

After apologizing in his introduction for not having held a forum like this sooner, Harrell, sitting on stage alongside the full school board, opened the floor to questions.

“First of all, I just want to say last time y’all had us on a time limit of sorts, and that’s not going to fly today,” said Brett Cross, the uncle of Uziyah Garcia. “There’s no other way to put it. We have a lot to say, and we won’t be silenced and we won’t be stopped. So if y’all had the idea of a time limit, it’s not going to get followed this time.”

Cross was referencing a press conference held by the special committee report Sunday on the failed police response to the shooting that saw 19 children and two teachers killed. Families were invited to attend and ask questions Sunday, and those invited — including the media and families — had to fill out compulsory paperwork required by the committee to ask a question. Many members of the community did, but due to time constraints, they were not given the opportunity to ask their questions.

Before the forum began Monday, attendees from the community sporting “Uvalde Strong” matching shirts placed photos of the victims on the seats in the front row facing the school board members.

When later asked by Cross if Arredondo was going to be fired, Harrell said, “That will be a decision… We will take the report into consideration, it will be a closed session.”

“I’ll tell you this: If he’s not fired by noon tomorrow, then I want your resignation and every single one of you board members,” Cross responded.

Vincente Salazar, the grandfather of Layla Salazar, addressed the school board saying, “Your system failed these families” and “it didn’t save our children. Your closed sessions that… didn’t save our children.”

“What we need to do now is put families in your sessions so we know what’s going on, what’s going on. And the way you’re spending your money for the security of our children,” Salazar continued. “We pay over 40% of the city budget for the school and for the police, and you hired trash. That’s not right.”

“I lost a loved one right here. My only granddaughter, I can hold myself together now because I’ve done my crime. Now it’s time to do my fighting. And you have seen me in the papers and you will see me in the papers a lot more. Because this isn’t the end. This is just the beginning of a war that you guys created for our children,” he added, to cheers from community members in the crowd.

Copyright © 2022, ABC Audio. All rights reserved.

Maryland’s gubernatorial primary highlights Trump and Hogan’s proxy battle

Maryland’s gubernatorial primary highlights Trump and Hogan’s proxy battle
Maryland’s gubernatorial primary highlights Trump and Hogan’s proxy battle
adamkaz/Getty Images

(WASHINGTON) — With Tuesday’s primary, a contentious race to succeed Maryland’s term-limited Gov. Larry Hogan is about to enter its next phase as Republicans seek to hold the seat of a popular incumbent while Democrats work to retake the governorship — in part by trying to influence the contest to get the GOP nod.

The front-runners in the Republican gubernatorial primary are state Del. Dan Cox, an attorney endorsed by former President Donald Trump, and former state Commerce Secretary Kelly Schulz, who was endorsed by Hogan.

The contest is something of a proxy battle between Trump and Hogan (a possible 2024 presidential contender and a major voice in the GOP’s anti-Trump minority) and their contrasting visions for their party’s success in Maryland.

Schulz could become the state’s first female governor. She has focused her campaign on issues such as the economy, education and creating a safer community, and she has leaned on her endorsement from Hogan — who is widely popular in the state — and her work in his Cabinet.

After the overturning of Roe v. Wade, Schulz said that she would not change Maryland law, which allows for abortion, but reaffirmed that she was personally opposed.

Her current stance on abortion is much different than the one she held in 2011, when she sponsored the “Maryland Personhood Amendment,” which would have allowed voters to decide to amend the state’s constitution to give rights to people “from the beginning of their biological development.” That amendment failed in the state’s Democratic legislature.

Cox says he is “running to restore freedom” and has focused in part on education, saying he supports parental rights in schools, opposes critical race theory (though that academic framework is not widely taught outside of universities) and has supported legislation against teaching gender identity in kindergarten through third-grade classrooms.

Cox opposes abortion without exception and he tried to sue Hogan over the state’s COVID-19 restrictions.

His record has been spotlighted by Democratic advertising during the primary — a tactic that Hogan criticized, arguing it was an attempt to boost Cox in the eyes of conservatives even though he may be weaker in the general election.

Cox called then-Vice President Mike Pence a “traitor” in a since-removed tweet after Pence certified the 2020 election results. In another deleted tweet, Cox also said he was arranging two buses to drive constituents to Trump’s Jan. 6, 2021, appearance near the White House shortly before a pro-Trump mob stormed the U.S. Capitol. (Cox said he wasn’t at the Capitol.)

In the Democratic gubernatorial primary, three leading candidates have emerged: former Democratic National Committee Chair Tom Perez, state Comptroller Peter Franchot and Wes Moore, an author and former nonprofit CEO who held a virtual fundraiser with Oprah Winfrey.

Another race drawing notice is the Republican primary for Maryland’s 6th Congressional District. Currently held by Democrat David Trone, several GOP contenders are fighting for the chance to go against him in November.

State Rep. Neil Parrot, who lost to Trone in 2020, is hoping for a rematch in November. However, the race could be shaken up by 25-year-old Matthew Foldi, a newcomer who has received a string of notable endorsements including from Hogan as well as House Minority Leader Kevin McCarthy, the No. 3 House Republican, Elise Stefanik, Donald Trump Jr. and others.

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Korean beer company searches for ‘real heroes’ who cleaned up massive bottle spill

Korean beer company searches for ‘real heroes’ who cleaned up massive bottle spill
Korean beer company searches for ‘real heroes’ who cleaned up massive bottle spill
omersukrugoksu/Getty Images

(SEOUL, South Korea) — Thousands of beer bottles cascading off a five-ton container truck seems like a disaster. But average citizens who came to the rescue are earning praise across South Korea for making the best of a bad situation.

The accident, which took place in June but is now gaining traction on social media as people try to track down the good Samaritans, came as a truck driver made a sharp turn in Chuncheon city, flooding the street with a torrent of beer and broken glass and engulfing the road in white foam in seconds.

The spill, which took place about 46 miles north of Seoul, the capital, could have easily precipitated a chain of additional accidents and an hourslong traffic jam — but 18 good Samaritans saved the day.

Immediately after the 2,000 bottles shattered on the road, the driver pulled over, then trudged toward the heap and began to gather the remains together.

Moments later, a passerby approached the driver and started to pile the crates up on one side. The owner of a local convenience store then brought brooms and dustpans and joined the effort.

The rain — along with their lack of umbrellas and raincoats — didn’t stop 16 more passersby from coming together and sweeping the road clean in less than a half-hour. When the work was done, they nonchalantly returned to their own affairs — as though it was just a matter of course.

Six days after the incident, Oriental Brewery Company revealed the footage of the beer spill cleanup captured by surveillance cameras. The company published notices and ads with footage of the incident to track down the good Samaritans and thank them. They used the slogan, “We are looking for the real heroes of Chuncheon city.”

“We wanted to find the citizens and express our gratitude to each of them in person,” Joo-hwan Baek, associate public relations director of Oriental Brewery Company, told ABC News. “We also hoped to spread the word of the good they did. It was very inspiring for us as well.”

The footage of the cleanup has been trending on South Korea’s social media and news ever since.

Viewers said the thoughtful gesture by passersby has warmed their hearts and restored their faith in humanity amid calamitous times.

“No one asked the citizens to jump in the rain and pitch in; it was a collective, voluntary effort with a selfless motive,” 20-year-old Se-yeon Hwang told ABC News. “The video was a powerful reminder of the good a supportive community with an altruistic heart can do.”

Seoul may now be seeing a butterfly effect.

A similar accident occurred less than a week after Oriental Brewery Company revealed the video. Another truck spilled hundreds of bottles of Korean vodka in the middle of a busy street in Incheon Metropolitan City.

Given the long tail of cars and buses following the truck, collateral damage appeared inevitable, but dozens of citizens who witnessed the accident came together and helped clear the highway in about a half-hour.

“It’s heartwarming to see pure goodwill like this, especially in an era of war, violence and widespread hate,” 52-year-old Mei Lee told ABC News. “I hope to see more acts of kindness in this world.”

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Luke Combs shares precious photos with son Tex, wife Nicole

Luke Combs shares precious photos with son Tex, wife Nicole
Luke Combs shares precious photos with son Tex, wife Nicole
ABC

Luke Combs is offering fans a look into his home life now that he’s a father, and the results are precious. 

The powerhouse singer took to Instagram to share a black-and-white photo that shows him holding his 1-month-old son, Tex, while planting a gentle kiss on wife Nicole‘s forehead as she embraces the two. Another intimate shot shows the singer sitting cozily with his son swaddled in a gray blanket, his shelves packed full of awards and trophies visible in the background. 

“This is what my days at home look like now. Couldn’t be happier about that,” Luke says in the captions alongside the stunning shots. “Been amazing getting to spend time with @nicolejcombs and little Tex.” 

Nicole also shared a few snaps from the session with newborn photographer Montgomery Lee, showing the couple laughing with their son in Luke’s arms and another of her smiling down at Tex. “One month with you,” she writes. 

Luke and Nicole welcomed Tex, their first child, on June 19. 

Copyright © 2022, ABC Audio. All rights reserved.

Asking Alexandria, Motionless in White members reflect on Chester Bennington’s legacy

Asking Alexandria, Motionless in White members reflect on Chester Bennington’s legacy
Asking Alexandria, Motionless in White members reflect on Chester Bennington’s legacy
Scott Legato/Getty Images

This Wednesday marks the fifth anniversary of late Linkin Park frontman Chester Bennington‘s death. Ahead of the somber milestone, Asking Alexandria guitarist Ben Bruce and Motionless in White frontman Chris “Motionless” Cerulli have spoken with ABC Audio about Bennington’s influence and continued legacy.

“When Linkin Park came out, Chester’s voice was so unique and so different in a time where there were lots of vocalists grumbling down the mic and sounding really aggressive,” Bruce says. “He had that capability, but then at the same time could just, like a switch, flip it off and he sounded like a f***ing Backstreet Boy. He had the most insanely perfect voice.”

And it wasn’t just how he was singing, but what he was singing about that made Bennington so impactful. Cerulli recalls first hearing Linkin Park in high school while “going through home troubles and bullying.”

“Hearing Chester sing words that connected with me on a level that was so deep and so honest and raw … I remember the first time I heard ‘Crawling,’ it just crushed me,” Cerulli says. “It’s rare to find someone that can really reach people on that level.”

That “hole,” as Cerulli puts it, “will never be filled,” but he continues to see Bennington and LP’s influence on bands today, including his.

“It’s cool to see that their legacy is never gonna die,” he says.

“On the 20th anniversary of his passing, people are gonna still hear that voice and instantly know it’s Chester Bennington,” Bruce adds. “That’s special, not a lot of people have that.”

Bennington died by suicide July 20, 2017, on what would’ve been his friend Chris Cornell‘s 53rd birthday. Cornell had died by suicide just two months earlier in May 2017.

If you are in crisis or know someone in crisis, contact the 988 Suicide & Crisis Lifeline by dialing 988, by calling 1-800-273-TALK (8255), or by visiting 988lifeline.org. You can also contact the Crisis Text Line by texting HOME to 741741.

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“I can tell you now that this is it:” Elton John promises this really is farewell

“I can tell you now that this is it:” Elton John promises this really is farewell
“I can tell you now that this is it:” Elton John promises this really is farewell
Dave J Hogan/Getty Images

It feels like Elton John‘s Farewell Yellow Brick Road tour has been going on forever, and it kind of has: It started back in 2018 and right now, it’s set to conclude in July 2023. Then, Elton swears, it’ll be over for good.

“I can tell you now that this is it,” he tells the British publication MusicWeek. “I will not be devoid of music, but as far as schlepping around the world doing shows, I don’t want to do it anymore. I’ve done it since I was 17.”

While Elton wants to wind things down touring-wise, his music career has had a big resurgence over the past few years. His set list includes both his first number-one hit — 1970’s “Your Song” — and his most recent number-one hit, which came last year with the Dua Lipa duet “Cold Heart.”

“I’m a 75-year-old heritage musician with a great catalog of songs and a great track record, but that doesn’t mean to say you stay relevant,” Elton points out. He thanks his management — which includes his husband David Furnish — for keeping him that way, and of course, Dua helped, too.

“She’s got everything there is to have as a female artist,” Elton says. “She’s bright, modest and not carried away by her own success.”

In fact, Elton feels young female artists like Dua and the bands HAIM and Wet Leg are “making the best music” these days. “It comes from innocence and pure joy and that, for me, is what music is about,” he says of those acts.

As for young male artists, Elton says he just got a listen to Lewis Capaldi’s eagerly anticipated sophomore album. While he reveals that Lewis has “apprehensions” about it, in his opinion, he says, “it’s a no-brainer.”

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Panic! at the Disco dropping new ’Viva Las Vengeance’ song this week

Panic! at the Disco dropping new ’Viva Las Vengeance’ song this week
Panic! at the Disco dropping new ’Viva Las Vengeance’ song this week
Mauricio Santana/Getty Images

Panic! at the Disco will be dropping another new song off their upcoming album Viva Las Vengeance this week.

The track is called “Middle of a Breakup” and is set to debut alongside a video on Wednesday, July 20.

The video will introduce us to a pair of characters named Boyd and Maggie. Notably, Viva Las Vengeance also has a song called “Something About Maggie.”

“Middle of a Breakup” will be the second cut to be released from Viva Las Vengeance, following the title track, which already hit #1 on Billboard‘s Alternative Airplay chart. The album arrives in full on August 19.

Panic! will launch a U.S. tour in support of Viva Las Vengeance in September.

Copyright © 2022, ABC Audio. All rights reserved.

Peter Frampton, Toto’s Steve Lukather among guitarists taking part in Joe Satriani’s G4 Experience camp

Peter Frampton, Toto’s Steve Lukather among guitarists taking part in Joe Satriani’s G4 Experience camp
Peter Frampton, Toto’s Steve Lukather among guitarists taking part in Joe Satriani’s G4 Experience camp
Dreamcatcher Events

Peter Frampton and Toto‘s Steve Lukather are among the talented guitarists who will participate in a new edition of Joe Satriani‘s G4 Experience guitar camp and concert series, taking place January 3-7, 2023, at the Hilton Lake Las Vegas Resort & Spa in Henderson, Nevada.

Other musicians who will be jamming and sharing their musical expertise at the four-day event include Deep Purple‘s Steve Morse, Testament‘s Alex Skolnick, longtime Rob Zombie guitarist John 5, Five Finger Death Punch‘s Andy James and blues rocker Eric Gales.

The G4 Experience, which is returning for the first time since 2019, offers guitar workshops, jam sessions, nightly concerts, meet-and-greets, photo opportunities, autograph-signing sessions, recreational activities and more.

The nightly concerts will feature Satriani performing with his longtime backing band — drummer Kenny Aronoff, bassist Bryan Beller and keyboardist Rai Thistlethwayte. It also will include appearances by special guests and faculty members.

In a message about the event, Satriani says about the diverse list of guest instructors, “We bring together this eclectic mix to show all the different sides of playing guitar. They’re all brilliant musicians with styles that are all over the map.”

He adds, “They all have such different jobs, they’ve made millions of people happy with their playing, and yet they do it so differently. Every one of these players comes with fantastic new insights and innovations on playing guitar.”

Visit G4Experience.com for more information and to reserve your place at the camp. Those who register now will receive a 10% discount.

Copyright © 2022, ABC Audio. All rights reserved.

‘The Bachelorette’ recap: The men strut their stuff for Gabby and Rachel

‘The Bachelorette’ recap: The men strut their stuff for Gabby and Rachel
‘The Bachelorette’ recap: The men strut their stuff for Gabby and Rachel
ABC/Craig Sjodin

After failing to talk to half of their 32 potential suitors and canceling the rose ceremony cancelation, Monday’s episode of The Bachelorette found Gabby and Rachel dealing with the difficult task of figuring out which of the remaining 29 men to invite on a group date.

Their solution was to make them compete in a pageant, while wearing speedos, to earn one of six spots at the group date after-party. The winners were AvenLoganBrandanJasonJohnny and Colin.

That led to an awkward moment for the Bachelorettes when both zeroed in on Logan as the recipient of their roses. Rachel’s ultimately went to Logan, while Gabby settled on Johnny.

Rachel’s first one-on-one date, a once-in-a-lifetime Zero-G Experience with Jordan V. ended with the 27-year-old Georgia-based drag racer being sent home. He never made it to see country singer Brett Young and rising country star Ashley Cooke perform their romantic hit, “Never Til Now.”

Gabby’s one-on-one date with Nate, which included a helicopter tour of Los Angeles, followed by a steamy hot tub session, went much better, ending with her pinning the date rose on him.

Meanwhile, back at the mansion, Chris‘ premature talk of fantasy suites and his intention to leave the competition if either girl was intimate with another contestant, without letting them know in advance, ticked off some of the men, who brought it to Gabby and Rachel’s attention at the pre-rose ceremony cocktail party. He was ultimately sent packing. That led to a brief confrontation between Chris and his accusers, after which, he was escorted off the premises.

At the rose ceremony, Brandan, Colin, JohnJustin B., Matt and Ryan were sent home.

Here are the remaining men after the rose ceremony:

Alec, 27, a wedding photographer from Houston, Texas
Aven, 28, a sales executive from San Diego, California
Erich, 29, a real estate analyst from Bedminster, New Jersey
Ethan, 27, an advertising executive from New York, New York
Hayden, 29, a leisure executive from Tampa, Florida
Jacob, 27, a mortgage broker from Scottsdale, Arizona
James, 25, a meatball enthusiast from Winnetka, Illinois
Jason, 30, an investment banker from Santa Monica, California
Johnny, 25, a realtor from Palm Beach Gardens, Florida
Jordan H., 35, a software developer from Tampa, Florida
Kirk, 29, a college football coach from Lubbock, Texas
Logan, 26, a videographer from San Diego, California
Mario, 31, a personal trainer from Naperville, Illinois
Michael, 32, a pharmaceutical salesman from Long Beach, California
Nate, 33, an electrical engineer from Chicago, Illinois
Quincey, 25, a life coach from Miami, Florida
Spencer, 27, an army officer from Chicago, Illinois
Termayne, 28, a crypto guy from Naperville, Illinois
Tino, 28, a general contractor from Playa Del Rey, California
Tyler, 25, a small business owner from Wildwood, New Jersey
Zach, 25, a tech executive from Anaheim Hills, California

The Bachelorette returns Monday at 8 p.m. ET on ABC.

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