Home-Based Wearable rTMS Therapy for Moderate to Severe Depression
Multicenter Randomized Controlled Trial Assessing Wearable Repetitive Transcranial Magnetic Stimulation for Home-Based Treatment of Depression
Background and Rationale
With rapid economic development and increasing societal pressures, the incidence of neuropsychiatric disorders has risen annually, ranking as the leading cause of disability worldwide and imposing a severe societal burden. Among these, depressive disorders represent a primary contributor. However, the efficacy and accessibility of transcranial magnetic stimulation (TMS) for depression face significant challenges. Key limitations include:
Low targeting accuracy with traditional localization methods. Limited clinical penetration of individualized precision paradigms .
In this context, wearable repetitive TMS (wrTMS) technology offers a transformative solution. The rTMS-Tiny device, developed by the Institute of Automation, Chinese Academy of Sciences, exemplifies this innovation with the following features:
Battery-powered with a pulse capacity exceeding 8,000 pulses per charge. Ultra-lightweight design: Total system weight <3 kg, coil helmet <2 kg (10% of conventional devices).
Performance parity: Comparable efficacy to standard rTMS systems while enabling protocols like Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) .
Advantages of rTMS-Tiny Portable Design and Wearable Application Ergonomically optimized helmet allows near-unrestricted daily activities during treatment .
Streamlined Operational Workflow Simplified protocols significantly reduce clinician workload . Enhanced Treatment Tolerability Improved comfort increases treatment completion rates and long-term adherence, directly enhancing therapeutic outcomes .
These advantages enable high-dose, intensive regimens (e.g., SAINT-like protocols) in routine clinical practice .
Scientific Imperative for a Multicenter RCT
A multicenter randomized controlled trial (RCT) of rTMS-Tiny is clinically and scientifically warranted to:
Test two core hypotheses:
Hypothesis 1: Efficacy of rTMS-Tiny in reducing depressive symptoms. Hypothesis 2: Safety of home-based rTMS-Tiny administration . Generate high-level evidence to advance neuromodulation into an era of precision, personalization, and artificial intelligence-driven therapy .
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Xiaoyun Guo
- Telefonnummer: 86-13524600458
- E-post: xiaoyunguo@163.com
Studieorter
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Shanghai, Kina
- Shanghai Mental Health Center (SMHC)
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
1. Inclusion Criteria
- Demographics Aged 18-65 years, any gender. Minimum education: primary school completion (≥6 years of formal education).
- Diagnostic and Severity Requirements Meet DSM-5 criteria for Major Depressive Disorder (MDD). Current moderate-to-severe depressive episode, defined by Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥18 .
Pharmacological Stability Stable antidepressant regimen for ≥4 weeks prior to enrollment, restricted to SSRIs (Selective Serotonin Reuptake Inhibitors).
Treatment-naïve patients permitted if no psychotropic medications used within the prior 4 weeks.
Mandatory maintenance of the same regimen throughout the study and post-treatment follow-up.
- Technical Feasibility Medically eligible for both structural MRI and resting-state functional MRI (fMRI) examinations.
2. Exclusion Criteria
- Psychiatric Comorbidities Any concurrent psychiatric diagnosis (e.g., autism spectrum disorder, severe cognitive impairment, epilepsy, mania, psychosis) .
- Neurological Structural Abnormalities Structural brain lesions increasing seizure risk or disrupting neural connectivity (e.g., brain tumors, history of stroke).
- Systemic Medical Conditions Unstable cardiovascular, respiratory, hepatic, renal diseases, or active malignancies.
- Contraindications to Procedures TMS contraindications: Metallic implants, pacemakers, history of epilepsy. MRI contraindications: Ferromagnetic implants, claustrophobia requiring sedation.
- Recent Neuromodulation Therapies Prior ECT (Electroconvulsive Therapy) or rTMS (repetitive Transcranial Magnetic Stimulation) within 3 months.
History of neurosurgical interventions for depression (e.g., deep brain stimulation).
6）Special Populations Pregnancy, lactation, or planning pregnancy during the study. 7）Medication Instability Planned adjustments to pharmacotherapy during the study period. 3. Withdrawal and Discontinuation Criteria
- Participant-Initiated Withdrawal Voluntary withdrawal: Participant withdraws consent (e.g., refusal to risk assignment to sham stimulation group).
Investigator-Initiated Withdrawal Non-compliance with inclusion criteria: Post-randomization discovery of ineligibility (e.g., symptom remission, medication non-adherence).
Serious Adverse Events (SAEs):
TMS-related SAEs (e.g., seizure, intractable headache, exacerbated suicidality).
- Study Discontinuation
Prespecified Efficacy Stoppage:
Interim analysis at n=30/group showing superiority of active intervention (Cohen's d >0.8) .
Safety-Driven Discontinuation:
Unacceptable risk profile (e.g., recurrent SAEs such as seizures or suicidality).
Loss to Follow-Up:
Trial termination if attrition rate exceeds pre-specified thresholds compromising statistical power (e.g., >20% dropout).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: rTMS-Tiny Treatment Group
Stimulation protocol using the rTMS-Tiny device with identical parameters to SNT: Stimulation mode Intermittent Theta-Burst Stimulation (iTBS) Burst composition: Each burst consists of 3 pulses at 50 Hz Train structure: 10 bursts repeated at 5 Hz per train (total train duration: 2 seconds) Inter-train interval: 8 seconds Session parameters Pulses per session: 1,800 pulses Session duration: 570 seconds (≈9.5 minutes) Inter-session interval: 50 minutes Daily frequency: 10 sessions per day Weekly schedule: 5 days per week Treatment course: 1 week (total 50 sessions) Total pulses per course: 1,800 pulses/session × 50 sessions = 90,000 pulses |
Stimulation protocol using the rTMS-Tiny device with identical parameters to SNT: Stimulation mode Intermittent Theta-Burst Stimulation (iTBS) Burst composition: Each burst consists of 3 pulses at 50 Hz Train structure: 10 bursts repeated at 5 Hz per train (total train duration: 2 seconds) Inter-train interval: 8 seconds Session parameters Pulses per session: 1,800 pulses Session duration: 570 seconds (≈9.5 minutes) Inter-session interval: 50 minutes Daily frequency: 10 sessions per day Weekly schedule: 5 days per week Treatment course: 1 week (total 50 sessions) Total pulses per course: 1,800 pulses/session × 50 sessions = 90,000 pulses |
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Placebo-jämförare: rTMS-Tiny Sham Stimulation Group
The key difference lies in the use of a sham stimulation coil instead of the rTMS-Tiny active treatment coil.
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The key difference lies in the use of a sham stimulation coil instead of the rTMS-Tiny active treatment coil.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change From Baseline in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
Tidsram: T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Depressive symptom severity was assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17; total score range, 0-52, with higher scores indicating more severe depression；Treatment Response Rate:≥50% reduction from baseline in HAMD-17 total score;Treatment Remission Rate:Post-treatment HAMD-17 Score < 8)
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T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Tidsram: T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Depressive symptom severity assessed with the Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item clinician-rated scale.
The total score ranges from 0 (minimum) to 60 (maximum); higher scores indicate more severe depressive symptoms (worse outcome), and lower scores indicate improvement.
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T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Beck Depression Inventory-II (BDI-II) Total Score
Tidsram: During treT1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month fatment
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Depressive symptom severity assessed with the Beck Depression Inventory-II (BDI-II), a 21-item self-report scale.
The total score ranges from 0 (minimum) to 63 (maximum); higher scores indicate more severe depressive symptoms (worse outcome), and lower scores indicate improvement.
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During treT1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month fatment
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Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
Tidsram: T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Anxiety symptom severity assessed with the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-rated scale.
The total score ranges from 0 (minimum) to 56 (maximum); higher scores indicate more severe anxiety symptoms (worse outcome), and lower scores indicate improvement.
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T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Change in Brief Symptom Inventory (BSI) Total Score
Tidsram: T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Overall psychological distress assessed with the Brief Symptom Inventory (BSI), a 53-item self-report scale (each item rated 0-4)，from 0 (minimum) to 212 (maximum).
The Global Severity Index (GSI) ranges from 0 (minimum) to 4 (maximum); higher scores indicate greater psychological distress (worse outcome), and lower scores indicate improvement.
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T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Change in Insomnia Severity Index (ISI) Total Score
Tidsram: T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Insomnia severity assessed with the Insomnia Severity Index (ISI), a 7-item self-report scale.
The total score ranges from 0 (minimum) to 28 (maximum); higher scores indicate more severe insomnia (worse outcome), and lower scores indicate improvement.
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T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Change in Montreal Cognitive Assessment (MoCA) Total Score
Tidsram: T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Global cognitive function assessed with the Montreal Cognitive Assessment (MoCA), a clinician-administered screening tool covering visuospatial/executive function, attention, language, memory, abstraction, and orientation.
The total score ranges from 0 (minimum) to 30 (maximum); higher scores indicate better cognitive function (better outcome), and lower scores indicate worsening.
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T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Treatment Participation Rate
Tidsram: T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Treatment adherence assessed as the participation rate: the number of rTMS treatment sessions actually completed by each participant, expressed as a percentage of the total number of scheduled treatment sessions.
Unit of measure: percentage of scheduled sessions completed.
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T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)
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Treatment Completion Rate (Percentage of Participants Completing the Full Planned rTMS Course)
Tidsram: At end of the peri-procedural period (within 1 week after the last rTMS session)
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Treatment adherence assessed as the completion rate: the percentage of enrolled participants who complete the full planned course of rTMS treatment.
Unit of measure: percentage of participants.
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At end of the peri-procedural period (within 1 week after the last rTMS session)
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v4.0
Tidsram: Throughout the peri-procedural period, from the first rTMS session through 1 week after the last session
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Safety and tolerability assessed as the number and incidence of participants experiencing treatment-emergent adverse events (TEAEs), with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Grade 1, mild, to Grade 5, death related to the adverse event).
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Throughout the peri-procedural period, from the first rTMS session through 1 week after the last session
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Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
- Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. doi: 10.1016/s0140-6736(85)92413-4. No abstract available.
- Weigand A, Horn A, Caballero R, Cooke D, Stern AP, Taylor SF, Press D, Pascual-Leone A, Fox MD. Prospective Validation That Subgenual Connectivity Predicts Antidepressant Efficacy of Transcranial Magnetic Stimulation Sites. Biol Psychiatry. 2018 Jul 1;84(1):28-37. doi: 10.1016/j.biopsych.2017.10.028. Epub 2017 Nov 10.
- Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29.
- George MS. Whither TMS: A One-Trick Pony or the Beginning of a Neuroscientific Revolution? Am J Psychiatry. 2019 Nov 1;176(11):904-910. doi: 10.1176/appi.ajp.2019.19090957.
- Cash RFH, Weigand A, Zalesky A, Siddiqi SH, Downar J, Fitzgerald PB, Fox MD. Using Brain Imaging to Improve Spatial Targeting of Transcranial Magnetic Stimulation for Depression. Biol Psychiatry. 2021 Nov 15;90(10):689-700. doi: 10.1016/j.biopsych.2020.05.033. Epub 2020 Jun 7.
- Cash RFH, Zalesky A, Thomson RH, Tian Y, Cocchi L, Fitzgerald PB. Subgenual Functional Connectivity Predicts Antidepressant Treatment Response to Transcranial Magnetic Stimulation: Independent Validation and Evaluation of Personalization. Biol Psychiatry. 2019 Jul 15;86(2):e5-e7. doi: 10.1016/j.biopsych.2018.12.002. Epub 2019 Jan 19. No abstract available.
- Brunoni AR, Chaimani A, Moffa AH, Razza LB, Gattaz WF, Daskalakis ZJ, Carvalho AF. Repetitive Transcranial Magnetic Stimulation for the Acute Treatment of Major Depressive Episodes: A Systematic Review With Network Meta-analysis. JAMA Psychiatry. 2017 Feb 1;74(2):143-152. doi: 10.1001/jamapsychiatry.2016.3644.
- Voineskos D, Blumberger DM, Zomorrodi R, Rogasch NC, Farzan F, Foussias G, Rajji TK, Daskalakis ZJ. Altered Transcranial Magnetic Stimulation-Electroencephalographic Markers of Inhibition and Excitation in the Dorsolateral Prefrontal Cortex in Major Depressive Disorder. Biol Psychiatry. 2019 Mar 15;85(6):477-486. doi: 10.1016/j.biopsych.2018.09.032. Epub 2018 Oct 18.
- Singh A, Erwin-Grabner T, Sutcliffe G, Antal A, Paulus W, Goya-Maldonado R. Personalized repetitive transcranial magnetic stimulation temporarily alters default mode network in healthy subjects. Sci Rep. 2019 Apr 4;9(1):5631. doi: 10.1038/s41598-019-42067-3.
- Siddiqi SH, Trapp NT, Hacker CD, Laumann TO, Kandala S, Hong X, Trillo L, Shahim P, Leuthardt EC, Carter AR, Brody DL. Repetitive Transcranial Magnetic Stimulation with Resting-State Network Targeting for Treatment-Resistant Depression in Traumatic Brain Injury: A Randomized, Controlled, Double-Blinded Pilot Study. J Neurotrauma. 2019 Apr 15;36(8):1361-1374. doi: 10.1089/neu.2018.5889. Epub 2019 Jan 7.
- Lisanby SH. Noninvasive Brain Stimulation for Depression - The Devil Is in the Dosing. N Engl J Med. 2017 Jun 29;376(26):2593-2594. doi: 10.1056/NEJMe1702492. No abstract available.
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