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Study record managers: refer to the Data Element Definitions if submitting registration or results information. Drug: Cabotegravir CAB tablet It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat. Drug: Rilpivirine RPV tablet It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with "TMC" and the other side with "25". Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose. Each vial is for single-dose use containing a withdrawable volume of 2.

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Study record managers: refer to the Data Element Definitions if submitting registration or results information. It was assessed by the blinded independent central review BICR. Participants responded to their symptom experience over the past 7 days using a 5-point Likert scale scored from "not at all" 0 to "very much" 4. The FOSI score ranged from 0 severely symptomatic to 32 asymptomatic.
With slightly over a million inhabitants within its city boundaries , Cologne is the largest city on the Rhine and also the most populous city of both the Rhine-Ruhr Metropolitan Region and the Rhineland. It is the largest city in the Central Franconian and Ripuarian dialect areas. Cologne was founded and established in Ubii territory in the 1st century AD as the Roman Colonia Claudia Ara Agrippinensium , the first word of which is the origin of its name.

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